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.
Hypogonadism is associated with increase in fat mass, decrease in muscle mass, accelerated bone loss, decreased libido and effects on mood. Androgen replacement in this context is clearly beneficial, and numerous studies have demonstrated improvements in bone and muscle mass, reductions in body fat and improvement in insulin sensitivity, libido and mood following treatment. Testosterone replacement leads to a dose-dependent decrease in adipose tissue and increase in muscle mass and strength. The principal focus of the proposed research is to evaluate the effect of androgel on lean body mass and regional adipose tissue mass (including hepatic and visceral fat) in type 2 diabetic patients with hypogonadism, a population that is likely to benefit from a reduction in adipose tissue and an increase in muscle mass.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Testosterone gel to be applied daily, starting does 5g.
placebo gel apply daily
Diabetes Center of the Southwest
Midland, Texas, United States
Mean absolute change in visceral adipose tissue mass in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy.
Time frame: 6 months
Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on:
Time frame: 6 months
Mean absolute change in hepatic fat measured by NMR spectroscopy.
Time frame: 6 months
Mean absolute change in total and regional adipose tissue mass measured by DEXA
Time frame: 6 months
Mean absolute change in total and regional lean body mass measured by DEXA.
Time frame: 6 months
Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD
Time frame: 6 months
Mean absolute change in hip BMC and BMD (mean of two hips)
Time frame: 6 months
Mean absolute change in spine BMC and lumbar spine (L1-L4) BMD
Time frame: 6 months
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