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Trial record 70 of 213 for:    "Hypogonadism" | "Androgens"

Testosterone Replacement in Men With Diabetes and Obesity

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ClinicalTrials.gov Identifier: NCT01127659
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : March 7, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypogonadism
Interventions Drug: testosterone
Drug: placebo
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese Testosterone Obese Placebo Eugonadal Diabetes Eugonadal Obese
Hide Arm/Group Description

active drug diabetes arm

testosterone: intramuscular every 2 weeks

placebo diabetes arm

placebo: saline intramuscular every 2 weeks

active drug obese arm

testosterone: intramuscular every 2 weeks

placebo obese arm

placebo: saline intramuscular every 2 weeks

no intervention no intervention
Period Title: Overall Study
Started 22 22 12 10 50 21
Completed 20 14 10 6 50 21
Not Completed 2 8 2 4 0 0
Arm/Group Title Diabetes With HH: Testosterone Obese With HH: Testosterone Obese With HH: Placebo Diabetes With HH: Placebo Eugonadal Diabetes Eugonadal Obese Total
Hide Arm/Group Description

active drug diabetes hypogonadal arm

testosterone: intramuscular every 2 weeks

active drug obese hypogonadal arm

testosterone: intramuscular every 2 weeks

placebo obese hypogonadal arm

placebo: saline intramuscular every 2 weeks

placebo diabetes hypogonadal arm

placebo: saline intramuscular every 2 weeks

diabetic men with normal testosterone obese non-diabetic men with normal testosterone Total of all reporting groups
Overall Number of Baseline Participants 22 12 10 22 50 21 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 12 participants 10 participants 22 participants 50 participants 21 participants 137 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
12
 100.0%
10
 100.0%
22
 100.0%
50
 100.0%
21
 100.0%
137
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 12 participants 10 participants 22 participants 50 participants 21 participants 137 participants
54  (7) 46  (9) 53  (7) 54  (9) 52  (9) 50  (8) 52  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 12 participants 10 participants 22 participants 50 participants 21 participants 137 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
22
 100.0%
12
 100.0%
10
 100.0%
22
 100.0%
50
 100.0%
21
 100.0%
137
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 12 participants 10 participants 22 participants 50 participants 21 participants 137 participants
22 12 10 22 50 21 137
1.Primary Outcome
Title Insulin Sensitivity
Hide Description measured by HE clamps (baseline and 6 mths)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Glucose infusion rate in HE clamps was measured
Arm/Group Title Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese With HH: Testosterone Obese With HH: Placebo Eugonadal Diabetes Eugonadal Obese
Hide Arm/Group Description:

active drug diabetes hypogonadal arm

testosterone: intramuscular every 2 weeks

Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min

placebo diabetes hypogonadal arm

placebo: saline intramuscular every 2 weeks

active drug obese hypogonadal arm

testosterone: intramuscular every 2 weeks

placebo obese hypogonadal arm

placebo: saline intramuscular every 2 weeks

diabetic men with normal testosterone

Glucose infusion rate: 10.29+/-5.55 mg/kg fat-free mass/min

obese non-diabetic men with normal testosterone
Overall Number of Participants Analyzed 20 14 10 6 50 21
Mean (Standard Deviation)
Unit of Measure: mg/kg fat free mass/min
baseline 6.66  (4.36) 5.12  (2.79) 11.37  (8.83) 12.93  (5.16) 10.29  (5.55) 12.30  (5.96)
6 months 8.73  (4.27) 5.06  (3.62) 12.96  (7.11) 14.57  (1.71) NA [1]   (NA) NA [1]   (NA)
[1]
These subjects did not undergo intervention
2.Secondary Outcome
Title Body Composition
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Inflammation
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese With HH: Testosterone Obese With HH: Placebo Eugonadal Diabetes Eugonadal Obese
Hide Arm/Group Description

active drug diabetes hypogonadal arm

testosterone: intramuscular every 2 weeks

placebo diabetes hypogonadal arm

placebo: saline intramuscular every 2 weeks

active drug obese hypogonadal arm

testosterone: intramuscular every 2 weeks

placebo obese hypogonadal arm

placebo: saline intramuscular every 2 weeks

diabetic men with normal testosterone obese non-diabetic men with normal testosterone
All-Cause Mortality
Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese With HH: Testosterone Obese With HH: Placebo Eugonadal Diabetes Eugonadal Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese With HH: Testosterone Obese With HH: Placebo Eugonadal Diabetes Eugonadal Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/50 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diabetes With HH: Testosterone Diabetes With HH: Placebo Obese With HH: Testosterone Obese With HH: Placebo Eugonadal Diabetes Eugonadal Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/50 (0.00%)   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paresh Dandona
Organization: University of Buffalo
Phone: 716) 961-9900
EMail: pdandona@kaleidahealth.org
Layout table for additonal information
Responsible Party: Paresh Dandona, University at Buffalo
ClinicalTrials.gov Identifier: NCT01127659     History of Changes
Other Study ID Numbers: NIH testosterone grant
R01DK075877 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2010
First Posted: May 21, 2010
Results First Submitted: January 13, 2017
Results First Posted: March 7, 2017
Last Update Posted: April 12, 2017