Trial Outcomes & Findings for Testosterone Replacement in Men With Diabetes and Obesity (NCT NCT01127659)

Results Overview

measured by HE clamps (baseline and 6 mths)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

137 participants

Primary outcome timeframe

baseline to 6 months

Results posted on

2022-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Diabetes With HH: Testosterone active drug diabetes arm testosterone: intramuscular every 2 weeks	Diabetes With HH: Placebo placebo diabetes arm placebo: saline intramuscular every 2 weeks	Obese Testosterone active drug obese arm testosterone: intramuscular every 2 weeks	Obese Placebo placebo obese arm placebo: saline intramuscular every 2 weeks	Eugonadal Diabetes no intervention. Only baseline data collected	Eugonadal Obese no intervention. Only baseline data collected
Overall Study STARTED	22	22	12	10	50	21
Overall Study COMPLETED	20	14	10	6	50	21
Overall Study NOT COMPLETED	2	8	2	4	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testosterone Replacement in Men With Diabetes and Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetes With HH: Testosterone n=22 Participants active drug diabetes hypogonadal arm testosterone: intramuscular every 2 weeks	Obese With HH: Testosterone n=12 Participants active drug obese hypogonadal arm testosterone: intramuscular every 2 weeks	Obese With HH: Placebo n=10 Participants placebo obese hypogonadal arm placebo: saline intramuscular every 2 weeks	Diabetes With HH: Placebo n=22 Participants placebo diabetes hypogonadal arm placebo: saline intramuscular every 2 weeks	Eugonadal Diabetes n=50 Participants diabetic men with normal testosterone	Eugonadal Obese n=21 Participants obese non-diabetic men with normal testosterone	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants	12 Participants n=4 Participants	10 Participants n=27 Participants	22 Participants n=483 Participants	50 Participants n=36 Participants	21 Participants n=10 Participants	137 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	54 years STANDARD_DEVIATION 7 • n=93 Participants	46 years STANDARD_DEVIATION 9 • n=4 Participants	53 years STANDARD_DEVIATION 7 • n=27 Participants	54 years STANDARD_DEVIATION 9 • n=483 Participants	52 years STANDARD_DEVIATION 9 • n=36 Participants	50 years STANDARD_DEVIATION 8 • n=10 Participants	52 years STANDARD_DEVIATION 8 • n=115 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	12 Participants n=4 Participants	10 Participants n=27 Participants	22 Participants n=483 Participants	50 Participants n=36 Participants	21 Participants n=10 Participants	137 Participants n=115 Participants
Region of Enrollment United States	22 participants n=93 Participants	12 participants n=4 Participants	10 participants n=27 Participants	22 participants n=483 Participants	50 participants n=36 Participants	21 participants n=10 Participants	137 participants n=115 Participants

PRIMARY outcome

Timeframe: baseline to 6 months

Population: Glucose infusion rate in HE clamps was measured

measured by HE clamps (baseline and 6 mths)

Outcome measures

Outcome measures
Measure	Diabetes With HH: Testosterone n=20 Participants active drug diabetes hypogonadal arm testosterone: intramuscular every 2 weeks Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min	Diabetes With HH: Placebo n=14 Participants placebo diabetes hypogonadal arm placebo: saline intramuscular every 2 weeks	Obese With HH: Testosterone n=10 Participants active drug obese hypogonadal arm testosterone: intramuscular every 2 weeks	Obese With HH: Placebo n=6 Participants placebo obese hypogonadal arm placebo: saline intramuscular every 2 weeks	Eugonadal Diabetes n=50 Participants diabetic men with normal testosterone. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention	Eugonadal Obese n=21 Participants obese non-diabetic men with normal testosterone. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention
Insulin Sensitivity baseline	6.66 mg/kg fat free mass/min Standard Deviation 4.36	5.12 mg/kg fat free mass/min Standard Deviation 2.79	11.37 mg/kg fat free mass/min Standard Deviation 8.83	12.93 mg/kg fat free mass/min Standard Deviation 5.16	10.29 mg/kg fat free mass/min Standard Deviation 5.55	12.30 mg/kg fat free mass/min Standard Deviation 5.96
Insulin Sensitivity 6 months	8.73 mg/kg fat free mass/min Standard Deviation 4.27	5.06 mg/kg fat free mass/min Standard Deviation 3.62	12.96 mg/kg fat free mass/min Standard Deviation 7.11	14.57 mg/kg fat free mass/min Standard Deviation 1.71	—	—

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Body composition using Total body fat mass (kg)

Body composition using Total body fat mass (kg)