Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diab… (NCT00440440) | Clinical Trial Compass
WithdrawnPhase 4
Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes
Stopped: study merged with another study
United States0Started 2009-08
Plain-language summary
The purpose of the study is to find out the effect of replacing testosterone in the form of a gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.
Who can participate
Age range35 Years – 75 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males with age 35-75 years inclusive.
* Evidence of hypogonadism: Hypogonadism will be defined as low total testosterone (\<300 ng/dL) and low calculated free testosterone (below 6.5ng/dL; calculated using testosterone and SHBG). Testosterone levels will be measured between 8 and 10 am. Subjects who have normal total but low free testosterone levels (or vice versa) will be asked to come again after one week to have their testosterone levels re-measured. They will be included in the study in their free and total testosterone levels are low on re-measurement.
* Type 2 diabetes
* Hemoglobin A1c \<8.0 %
* Subjects on medications for diabetes will be allowed as long as they are on stable doses of these compounds for at least 6 weeks. The dose of thiazolidinediones will have to be stable for 3 months prior to the study. The dosage of diabetic medications will not be changed during the study.
Exclusion Criteria:
* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
* Hepatic disease (transaminase \> 3 times normal)
* Renal impairment (serum creatinine \> 1.5)
* Chronic steroid therapy
* Use of testosterone or other androgens (such as DHEA) in the last 3 months
* Panhypopituitarism
* HIV or hepatitis C
* Subjects will be excluded from the study for history of prostate or breast cancer, gonadal endocrine disorders
* Current or recent history of major psychiatri…
What they're measuring
1
Mean absolute change in visceral adipose tissue mass in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy.