Hypogonadism in Young Men With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01155518|
Recruitment Status : Terminated (lack of funding)
First Posted : July 1, 2010
Last Update Posted : April 19, 2018
|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|
|Actual Primary Completion Date :||December 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|