Hypogonadism in Young Men With Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01155518|
Recruitment Status : Terminated (lack of funding)
First Posted : July 1, 2010
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadotropic Hypogonadism Type 2 Diabetes||Drug: testosterone Drug: clomiphene Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men|
|Study Start Date :||June 2010|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
intramuscular injections every 2 weeks
intramuscular every 2 weeks
oral drug thrice a week
thrice a week
Placebo Comparator: placebo for testosterone
placebo for testosterone arm
intramuscular saline injections every 2 weeks
Placebo Comparator: placebo for clomiphene
oral placebo for clomiphene arm
- insulin resistance [ Time Frame: 6 months ]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.
- inflammation [ Time Frame: 6 months ]HH in young T2D men is associated with increased expression and protein content of mediators of inflammation and insulin resistance in MNC, muscle and adipose tissue. Treatment with T and CC decreases inflammation and the expression of proteins that decrease insulin signal transduction.
- body composition [ Time Frame: 6 months ]
To compare the total subcutaneous fat mass and lean body mass of T2D men with and without HH as measured by dual energy x-ray absorptiometry (DEXA). Abdominal MRI scan will be carried out to estimate visceral and hepatic fat.
To compare the fat mass and lean body mass after treatment with T or CC for 6 months.
- sexual function and spermatogenesis [ Time Frame: 6 months ]HH in young T2D men is associated with a decrease in testicular volume, a decrease in spermatozoal numbers, abnormal spermatozoal morphology and function, decreased sexual function and depressed mood as compared to age matched T2D men without HH and healthy lean controls. T and CC treatment will improve sexual function and mood. CC treatment can increase T concentrations, testicular size and spermatogenesis in T2D men with HH.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155518
|United States, New York|
|Millard Fillmore Gates Hospital|
|Buffalo, New York, United States, 14209|
|Principal Investigator:||Sandeep Dhindsa, MBBS||SUNY at Buffalo|