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Lifestyle Intervention and Testosterone Replacement in Obese Seniors (LITROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367105
Recruitment Status : Completed
First Posted : February 20, 2015
Results First Posted : August 31, 2020
Last Update Posted : July 26, 2022
Sponsor:
Collaborators:
Michael E. DeBakey VA Medical Center
Baylor College of Medicine
Biomedical Research Institute of New Mexico
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity and Hypogonadism
Interventions Drug: Testosterone
Other: Lifestyle Therapy
Drug: Placebo
Enrollment 83
Recruitment Details Participants were recruited through advertisements and review of medical records at the Michael E DeBakey VA Medical Center.
Pre-assignment Details After obtaining written informed consent, potential participants underwent a comprehensive medical screening procedure, including an exercise stress test. If they were found eligible based on the inclusion/exclusion criteria, they were randomized into one of the two treatment groups.
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Period Title: Overall Study
Started 41 42
Completed 36 34
Not Completed 5 8
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy Total
Hide Arm/Group Description

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Total of all reporting groups
Overall Number of Baseline Participants 41 42 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 42 participants 83 participants
72.2  (3.2) 73.6  (3.7) 73.4  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
42
 100.0%
83
 100.0%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Hispanic or Latino
8
  19.5%
19
  45.2%
27
  32.5%
Not Hispanic or Latino
32
  78.0%
20
  47.6%
52
  62.7%
Unknown or Not Reported
1
   2.4%
3
   7.1%
4
   4.8%
[1]
Measure Description: Ethnicity was reported by the participants
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
American Indian or Alaska Native
1
   2.4%
0
   0.0%
1
   1.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.4%
1
   1.2%
Black or African American
14
  34.1%
20
  47.6%
34
  41.0%
White
22
  53.7%
19
  45.2%
41
  49.4%
More than one race
2
   4.9%
2
   4.8%
4
   4.8%
Unknown or Not Reported
2
   4.9%
0
   0.0%
2
   2.4%
[1]
Measure Description: Race was reported by the participants
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 42 participants 83 participants
41 42 83
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 41 participants 42 participants 83 participants
36.9  (4.9) 37.1  (5.6) 37.0  (5.2)
[1]
Measure Description: The body-mass index is the weight in kilograms divided by the square of the height in meters
Total testosterone level   [1] 
Mean (Standard Deviation)
Unit of measure:  Ng/dl
Number Analyzed 41 participants 42 participants 83 participants
218  (43) 210  (63) 214  (54)
[1]
Measure Description: Measured in the blood during early am in the fasting state.
Physical Performance Test score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 42 participants 83 participants
28.3  (3.1) 28.5  (2.8) 28.4  (2.9)
[1]
Measure Description: The test includes walking 50 ft, putting on and removing a coat, picking up a penny, standing from a chair, lifting a book, climbing a flight of stairs, climbing up and down 4 flight of stairs, and performing a 360-degree turn. The score for each task ranges from 0 to 4; a perfect score is 36. Higher scores indicate better physical function.
1.Primary Outcome
Title Change in the Physical Performance Test
Hide Description The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate better physical function.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
4.6  (0.3) 4.9  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Endurance Capacity
Hide Description Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: ml/kg/min
2.8  (0.3) 4.0  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Functional Status
Hide Description

Assessed by the Functional Status Questionnaire. Score range: 0 to 36 with higher scores indicating better functional status

Provides information of the participants ability to perform activities of daily living.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
2.9  (0.4) 3.1  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .97
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Body Weight
Hide Description Measured after an overnight fast using calibrated scales
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: kilograms
-10.6  (0.6) -9.8  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Lean Body Mass
Hide Description Assessed by using dual-energy x-ray absorptiometry
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: kg
-2.4  (0.2) -1.2  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Fat Mass
Hide Description Assessed by using dual-energy x-ray absorptiometry
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: kg
-8.2  (0.4) -8.0  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Thigh Muscle Volume
Hide Description Assessed by using magnetic resonance imaging
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: cm^3
-68  (10) -25  (10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Thigh Fat Volume
Hide Description Volume of fat in the thigh by measured by magnetic resonance imaging
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: cm^3
-292  (31) -262  (32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .67
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Total Hip Bone Mineral Density
Hide Description Assessed by using dual-energy x-ray absorptiometry
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: gm/cm^2
-0.013  (0.002) 0.007  (0.002)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline valued adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.019
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Lumbar Spine Bone Mineral Density
Hide Description As measured by Dual energy x-ray absorptiometry
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: gm/cm^2
0.004  (0.004) 0.007  (0.004)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.003
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Muscle Strength
Hide Description assessed by total1-repetition maximum (the maximal weight lifted at one time; the totals are the sum of the maximal weights lifted in the biceps curl, bench press, 387 seated row, knee extension, knee flexion, and leg press exercises).
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: kg
72  (5) 68  (5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Static Balance
Hide Description assessed by one leg limb stance
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: seconds
4.5  (0.9) 5.0  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Dynamic Balance
Hide Description Assessed by using the obstacle course
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Plus Lifestyle Therapy Placebo Plus Lifestyle Therapy
Hide Arm/Group Description:

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: seconds
-2.9  (0.3) -3.2  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone Plus Lifestyle Therapy, Placebo Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Gait Speed
Hide Description Determined by measuring the time needed to walk 25 ft.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: m/min
8.6  (1.3) 8.2  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Baseline value adjusted
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Composite Cognitive Z-score
Hide Description

Test of overall cognitive performance formed by averaging the standardized scores for several domains of cognitive function (attention, memory, executive, language, global). Higher scores indicate better cognitive status.

The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of the baseline scores (units on a scale). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: z-score
.273  (.061) .557  (.065)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.284
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change in Modified Mini-mental Exam
Hide Description Test of global cognition with components for orientation, registration, attention, language, praxis, and immediate and delayed memory. Score ranges from 0 to 100 with higher scores indicate better cognition.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
1.2  (0.3) 2.1  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .16
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Stroop Interference
Hide Description

Assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: score on a scale
4.6  (0.7) 3.1  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change in Word List Fluency
Hide Description Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
0.2  (0.5) 0.9  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change in Ray Auditory Verbal Learning Test
Hide Description

The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information.

Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
3.1  (0.9) 7.0  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value and years if education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change in Trail A
Hide Description

Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a greater focus on attention).

Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
-7.7  (1.4) -13.9  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.6
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change in Trail B
Hide Description

Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a focus on executive function)

Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
-10.2  (2.9) -19.5  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.8
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change in Symbol Digital Modalities Test
Hide Description

Assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed.

Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
1.1  (0.5) 2.8  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values and years of education as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change in Trabecular Bone Score
Hide Description

The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis.

Minimum score is 0, there is no maximum value. Higher scores indicate better bone microarchitecture.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
0.12  (.01) .11  (.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .65
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .01
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change in C-terminal Telopeptide
Hide Description biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: µg/L
0.530  (.012) 0.002  (0.012)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.553
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change in N-terminal Propeptide of Type I Procollagen
Hide Description Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: µg/L
-4.7  (1.4) 1.5  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.5
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change in Insulin Growth Factor-1
Hide Description Measured by immunoassay methodology
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: ng/mL
11.8  (2.8) 16.9  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments Baseline value adjusted
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.5
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change in Trabecular Bone Score (Trabecular Bone Quality)
Hide Description

assessed by trabecular bone score (TBS), a newly developed index for assessing trabecular bone quality and fracture risk.

TBS is a bone texture parameter that quantifies cancellous bone microachitecture, which is key in determining bone strength and resistance to fracture, by computing raw data from dual energy x-ray absorptiometry of the lumbar spine.

There are no minimum or maximum values. Higher scores mean better outcome.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone + Lifestyle Therapy Placebo + Lifestyle Therapy
Hide Arm/Group Description:

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Overall Number of Participants Analyzed 41 42
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.11  (.01) 0.12  (.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone + Lifestyle Therapy, Placebo + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.01
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change in Levels of 25-hydroxyvitamin D
Hide Description assessed by using immunoassay methodology
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: ng/mL
6.2  (1.1) 8.3  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments Baseline value adjusted
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.4
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change in Parathyroid Hormone Level
Hide Description Measured by immunoassay methodology as marker of bone metabolism
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: pg/mL
12.9  (2.0) 9.0  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments Baseline value adjusted
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change in High-sensitivity C-reactive Protein (Inflammatory Marker)
Hide Description measured in the peripheral blood using immunoassay technique methodology
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: mg/dl
.19  (.05) .18  (.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .01
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change in Interleukin-6
Hide Description Measured from fasting serum using immunoassay technique as marker of inflammation
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: pg/mL
-1.1  (0.2) -1.0  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Estimation Comments [Not Specified]
32.Other Pre-specified Outcome
Title Change in Total Testosterone Levels
Hide Description as measured in the peripheral blood by liquid chromatography/mass spectrometry
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: ng/dL
60  (21) 306  (23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -252
Estimation Comments [Not Specified]
33.Other Pre-specified Outcome
Title Change in Estradiol
Hide Description As measured by LC-MS/MS
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone + Lifestyle Therapy Placebo + Lifestyle Therapy
Hide Arm/Group Description:

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: pg/dL
-3.0  (2.7) 22.1  (2.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone + Lifestyle Therapy, Placebo + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.9
Estimation Comments [Not Specified]
34.Other Pre-specified Outcome
Title Change in Hematocrit
Hide Description the ratio of the volume of red blood cells to the total volume of blood.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: percentage of red blood cells
-0.5  (0.3) 2.4  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Estimation Comments [Not Specified]
35.Other Pre-specified Outcome
Title Change in Prostate Specific Antigen
Hide Description blood test to screen for prostate cancer
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: ng/mL
0.2  (0.1) 0.5  (0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Estimation Comments [Not Specified]
36.Other Pre-specified Outcome
Title Change in Short Form Health Survey (SF-36) Quality of Life Physical Component
Hide Description Using Short Form-36 of Life Questionnaire Physical Component subscale. Minimum score is 0, Maximum score is 100. Higher scores indicate better outcome.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
5.5  (0.8) 7.1  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments Baseline values as covariates
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Estimation Comments [Not Specified]
37.Other Pre-specified Outcome
Title Change in International Prostate Symptom Score
Hide Description Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35. Higher scores mean worse outcome.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.5) -0.1  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Estimation Comments [Not Specified]
38.Other Pre-specified Outcome
Title Change in Triglyceride Levels
Hide Description Blood samples obtained in the fasting state as part of measurements of lipid profile
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: mg/dl
-39  (5.4) -31  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline value adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.1
Estimation Comments [Not Specified]
39.Other Pre-specified Outcome
Title Change in HDL-cholesterol
Hide Description Blood samples obtained in the fasting state as part of measurements of lipid profile
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: mg/dl
5.4  (1.0) 0.2  (1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.3
Estimation Comments [Not Specified]
40.Other Pre-specified Outcome
Title Change in Waist Circumference
Hide Description Waist circumference as measured horizontally at the midpoint between the highest point of the iliac crest and the lowest portion of the 12th rib in the standing position.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: cm
-9.4  (0.5) -8.4  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Estimation Comments [Not Specified]
41.Other Pre-specified Outcome
Title Change in Glucose
Hide Description Measured in the blood after overnight fast
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: mg/dl
-22.5  (3.7) -17.1  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy, Testosterone Plus Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.6
Estimation Comments [Not Specified]
42.Other Pre-specified Outcome
Title Change in Mood
Hide Description Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30).
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: score on a scale
-1.43  (0.38) -1.39  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline values adjusted
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Estimation Comments [Not Specified]
43.Other Pre-specified Outcome
Title Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network
Hide Description Functional connectivity was measured with seeds of the DMN (medial prefrontal cortex [MPFC] and posterior cingulate cortex [PCC]). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects per group is less than the overall number of subjects enrolled in the trial because this was an add-on outcome later in the study. Moreover, the analyses are limited to subjects with complete evaluable pre and post-MRI data.
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 6 11
Measure Type: Count of Participants
Unit of Measure: Participants
DMN (MPFC seed)
0
   0.0%
0
   0.0%
DMN (PCC seed)
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy, Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments A priori threshold = voxel p<.001, cluster p<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Number of participants
Estimated Value 0
Estimation Comments [Not Specified]
44.Other Pre-specified Outcome
Title Change in Skeletal Muscle Growth Factor (MYOD1)
Hide Description Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Plus Lifestyle Therapy Testosterone Plus Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 20 18
Mean (Standard Error)
Unit of Measure: log2fold
0.23  (0.05) 0.53  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Lifestyle Therapy
Comments 6 months vs Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone Plus Lifestyle Therapy
Comments 6 months vs Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
45.Other Pre-specified Outcome
Title Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)
Hide Description assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description:

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: mg/cm^3
-3.1  (1.3) -0.3  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method Mixed Models Analysis
Comments Final vs baseline
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone + Lifestyle Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Mixed Models Analysis
Comments Final vs baseline
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Hide Arm/Group Description

Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

Placebo: Placebo gel for testosterone

Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training

Testosterone: Daily testosterone gel applied once daily in the morning to intact skin

Lifestyle Therapy: Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week

All-Cause Mortality
Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/41 (2.44%)      1/42 (2.38%)    
Blood and lymphatic system disorders     
Idiopathic thrombocytopenia   0/41 (0.00%)  0 1/42 (2.38%)  1
Cardiac disorders     
Congestive heart failure   1/41 (2.44%)  1 1/42 (2.38%)  1
Cardiac arrest   1/41 (2.44%)  1 0/42 (0.00%)  0
Endocrine disorders     
Hyperosmolar hyperglycemic state   0/41 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders     
Bleeding peptic ulcer   1/41 (2.44%)  1 0/42 (0.00%)  0
Duodenitis   0/41 (0.00%)  0 1/42 (2.38%)  1
Intestinal obstruction   0/41 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders     
Ankle fracture   0/41 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders     
Acute kidney injury   1/41 (2.44%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism   0/41 (0.00%)  0 1/42 (2.38%)  1
Skin and subcutaneous tissue disorders     
Cellulitis   1/41 (2.44%)  1 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Lifestyle Therapy Testosterone + Lifestyle Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/41 (29.27%)      6/42 (14.29%)    
Metabolism and nutrition disorders     
hypoglycemia, asymptomatic and symptomatic   4/41 (9.76%)  4 4/42 (9.52%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Elevated PSA   4/41 (9.76%)  4 1/42 (2.38%)  1
Vascular disorders     
Dizziness/orthostasis   4/41 (9.76%)  4 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dennis T Villareal, MD
Organization: Michael E DeBakey VA Medical Center
Phone: 713-794-7156
EMail: dennis.villareal@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02367105    
Other Study ID Numbers: ENDA-034-12F
CX000906 ( Other Grant/Funding Number: VA CSRD )
First Submitted: January 21, 2015
First Posted: February 20, 2015
Results First Submitted: July 22, 2020
Results First Posted: August 31, 2020
Last Update Posted: July 26, 2022