Trial Outcomes & Findings for Hypogonadism in Young Men With Type 2 Diabetes (NCT NCT01155518)

Results Overview

To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

6 months

Results posted on

2019-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks	Clomiphene oral drug thrice a week clomiphene: thrice a week	Eugonadal Obese men with obesity and normal testosterone levels	Control lean healthy men with normal testosterone levels
Overall Study STARTED	1	1	1	2
Overall Study COMPLETED	1	0	1	2
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypogonadism in Young Men With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=1 Participants intramuscular injections every 2 weeks testosterone: intramuscular every 2 weeks	Clomiphene n=1 Participants oral drug thrice a week clomiphene: thrice a week	Placebo for Testosterone placebo for testosterone arm placebo: intramuscular saline injections every 2 weeks	Placebo for Clomiphene oral placebo for clomiphene arm placebo: oral	Eugonadal Obese n=1 Participants obese men with normal testosterone level	Lean n=2 Participants healthy lean men (control)	Total n=5 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 0 • n=99 Participants	30 years STANDARD_DEVIATION 0 • n=107 Participants	—	—	36 years STANDARD_DEVIATION 0 • n=31 Participants	21 years STANDARD_DEVIATION 1 • n=30 Participants	30 years STANDARD_DEVIATION 7 • n=3 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	2 Participants n=30 Participants	5 Participants n=3 Participants
Region of Enrollment United States	1 participants n=99 Participants	1 participants n=107 Participants	—	—	1 participants n=31 Participants	2 participants n=30 Participants	5 participants n=3 Participants

PRIMARY outcome

Timeframe: 6 months

Population: study terminated

To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.