Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men

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: NCT00365794
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Fred Sattler, MD, University of Southern California

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Aging
Obesity
Insulin Resistance
Hypogonadism
Intervention Drug: Topical testosterone gel 10 g/day
Enrollment 22
Recruitment Details Potential subjects were primarily recruited from 2011 to 2013 and were evaluated and studied at the University of Southern California CTSI Clinical Trials Unit. 22 subjects met all eligibility requirements and begun study therapy with testosterone gel. Two did not complete treatment. Thus, 20 completed all evaluations as planned.
Pre-assignment Details

Consenting subjects were evaluated for eligibility and had to be:

Men 60 years-or-older, with morning testosterone <400ng/dL, waist circumference ≥102cm, and evidence of insulin resistance; HgbA1c of 5.7-6.4% [20] or HOMA-IR ≥4.0. Exclusion criteria included diabetes, PSA ≥4.0μg/L, hct ≥50%, AST ≥2X ULN, concurrent inflammatory condition.

Arm/Group Title Single Arm
Hide Arm/Group Description

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Period Title: Overall Study
Started [1] 22 [2]
Completed 20
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
[1]
All milestones were met 1) target number enrolled and 2) all finished study therapy and measurements
[2]
22 subjects were enrolled since only 20 completed all post treatment measures.
Arm/Group Title Single Arm
Hide Arm/Group Description open label treatment with testosterone gel
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
67.5
(62.0 to 78.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
0
   0.0%
Male
20
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
AM total testosterone level  
Median (Full Range)
Unit of measure:  Nmoles/liter
Number Analyzed 20 participants
10.6
(5.2 to 13.9)
waist circumference  
Median (Full Range)
Unit of measure:  Centimeters
Number Analyzed 20 participants
114
(104 to 122)
blood panels  
Median (Full Range)
Unit of measure:  Mmole/liter
Number Analyzed 20 participants
total cholesterol
4.61
(3.00 to 6.73)
LDL cholesterol
3.11
(0.98 to 5.00)
HDL cholesterol
1.06
(0.62 to 1.76)
Fasting triglycerides
1.59
(0.72 to 4.87)
Patient history at enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Family history of diabetes
4
  20.0%
Smoking ever
14
  70.0%
Smoking currently
0
   0.0%
On Rx for lipid disorder
12
  60.0%
On Rx for hypertension
10
  50.0%
Body compotion   [1] 
Median (Full Range)
Unit of measure:  Kilograms
Number Analyzed 20 participants
Total body mass
104.5
(84.4 to 133.6)
Total fat mass
34.6
(24.3 to 57.1)
Trunk fat mass
19.3
(13.6 to 30.0)
Extremity fat mass
12.9
(9.1 to 27.6)
Total lean body mss
64.3
(47.1 to 75.0)
Extremity lean mass
29.1
(21.2 to 34.1)
[1]
Measure Description: kilograms as measured by DEXA
Percentage of body fat  
Median (Full Range)
Unit of measure:  Percentage
Number Analyzed 20 participants
31.5
(23.9 to 42.7)
Insulin senstivity  
Median (Full Range)
Unit of measure:  dL/min per μU/mL;
Number Analyzed 20 participants
Whole body insulin sensivity
2.93
(1.07 to 8.51)
Hepatic glucose output
2.89
(0.03 to 7.83)
Rate of glucose disposal
2.93
(1.07 to 8.51)
HOMA-IR  
Median (Full Range)
Unit of measure:  microU/L) x fasting glucose (nmol/L)/22.
Number Analyzed 20 participants
3.55
(0.64 to 11.4)
Basal free fatty acids  
Median (Full Range)
Unit of measure:  mEq/L
Number Analyzed 20 participants
0.35
(0.24 to 0.53)
Change in glucose clamp free fatty acids over 0 to 4 hours  
Median (Full Range)
Unit of measure:  Grams
Number Analyzed 20 participants
0.30
(0.17 to 0.41)
Hepatic lipid   [1] 
Median (Full Range)
Unit of measure:  Ratio
Number Analyzed 20 participants
0.11
(0.01 to 1.13)
[1]
Measure Description: Measurement is adjusted for water content and commonly reported as ratio
Intramyocellular lipid (IMCL)   [1] 
Median (Full Range)
Unit of measure:  Ratio
Number Analyzed 20 participants
5.8
(0.2 to 30)
[1]
Measure Description: IMCL is commonly adjusted for creatine (Cr) content and reported as a raio
1.Primary Outcome
Title Change in Total Mass and Regional Adipose Adiposiy
Hide Description Change in total body mass, total fat mass, trunk fat, and extremity fat
Time Frame Baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data for one participant was not available
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: kilograms
Total body mass
0.3
(-4.8 to 4.1)
Total fat mass
-1.4
(-7.4 to 2.0)
Trunk fat mass
-0.9
(-4.6 to 0.2)
Extremity fat mass
-0.7
(-3.0 to 2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Total body mass
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Total fat mass
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in Hepatic Lipid
Hide Description Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two.
Time Frame Baseline to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for one subject
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment.

Topical testosterone gel 10 g/day: Testosterone gel therapy for 20 weeks

Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: ratio
-36
(-84 to 127)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments No adjustment in p for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Intramyocellular Lipid (IMCL)
Hide Description IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio
Time Frame Baseline to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
data not available for 5 subjects
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: ratio
-30
(-85 to 43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Percentage of Total Body Fat
Hide Description Percentage of total body fat is quantified by DEXA scanning
Time Frame Baseline and 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for one subject
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: percentage of total body fat
-1.6
(-6.5 to 0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments No adjustment for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])
Hide Description In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal [Rd],hepatic glucose output [HGO]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels.
Time Frame Baseline and 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: dL/min per μU/mL
Whole body insulin sensitiity
1.05
(-2.44 to 3.73)
hepaic glucose output (HGO)
-0.16
(-2.58 to 7.49)
peripheral glucose disposal (Rd)
1.16
(-3.08 to 3.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Skeletal Muscle Mass by DEXA
Hide Description Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.
Time Frame Baselne to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: kilograms
1.2
(-1.1 to 4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Plasma Lipids
Hide Description [Not Specified]
Time Frame Baseline to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: mg/dL
Fasting triglycerides
-0.33
(-2.70 to 0.43)
Total cholesterol
-0.52
(-1.74 to 0.88)
LDL cholesterol
-0.23
(-1.45 to 0.70)
HDL cholesterol
-0.10
(-0.60 to 0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.
Type of Statistical Test Other
Comments Test for fasting triglycerides
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel
Type of Statistical Test Other
Comments Test for total cholesterol
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel
Type of Statistical Test Other
Comments Test for LDL cholesterol
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel
Type of Statistical Test Other
Comments Test for HDL cholesterol
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in HOMA-IR
Hide Description HOMA-IR is a measure of insulin resistance
Time Frame Baseline to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: microU/L) x fasting glucose (nmol/L)/22
-0.75
(-6.94 to 4.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change in Basal FFAs in Plasma
Hide Description FFA (plasma free fatty acids) are measure of lipid metabolism
Time Frame Baseline to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: mEq/L
-0.1
(-0.22 to 0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change in Plasma Free Fatty Acids During Glucose Clamp
Hide Description [Not Specified]
Time Frame Baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Open label treatment with each participant serving as his own control. Data is compared before and after treatment.

Topical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: grams
-0.1
(-0.12 to 0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 20 weeks for each participant
Adverse Event Reporting Description No serious adverse events occurred.
 
Arm/Group Title Open Label Testosterone Treatment
Hide Arm/Group Description

No serious adverse events occurred

PSA and Framingham CV Disease Risk Score did not increase

All-Cause Mortality
Open Label Testosterone Treatment
Affected / at Risk (%)
Total   0/20 (0.00%)    
Hide Serious Adverse Events
Open Label Testosterone Treatment
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Testosterone Treatment
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Skin and subcutaneous tissue disorders   
Skin irritation  1  1/20 (5.00%)  1
1
Term from vocabulary, ACTG
Indicates events were collected by systematic assessment

The primary limitation of this small pilot study is that it does not have a control group.

It is also likely under-powered and thus unable to show significance differences for some measurements.

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: Fred Sattler, MD
Organization: University of Southern California
Phone: 323-409-4635
EMail: fsattler@usc.edu
Layout table for additonal information
Responsible Party: Fred Sattler, MD, University of Southern California
ClinicalTrials.gov Identifier: NCT00365794    
Other Study ID Numbers: GCRC Protocol 1156
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: March 22, 2017
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019