This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.
In this proposal, we will examine the relationship between hypogonadism and insulin sensitivity. The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship between these two conditions is unknown. Therefore, we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity. Data obtained from this preliminary investigation, will hopefully result in a hypothesis that can be tested in a larger, more rigorous trial in the future.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
testosterone gel, applied daily. Dosed to achieve testosterone level \<500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
Placebo gel, 2.5g for each gel packet
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Change in insulin sensitivity as measured by HOMA-IR
Time frame: 18 weeks
Changes in parameters of the Metabolic Syndrome
Time frame: 18 weeks
Changes in body composition
Time frame: 18 weeks
Changes in total and high MW adiponectin levels
Time frame: 18 weeks
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