Hypogonadism Clinical Trial
Official title:
Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.
The overall aim of this study is to examine the effect of testosterone on insulin
sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good
general health and 2 groups of men will be studied in this protocol:
1. Thirty healthy normal men aged 18-75 years with normal blood pressure, normal
testosterone levels, and not taking any medications known to influence glucose
homeostasis or testosterone
2. Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism
(IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin
levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men
will be on no medications known to influence glucose homeostasis and will have been off
hormone therapy for a suitable washout period depending on the type of prior androgen
replacement.
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Intervention Model: Crossover Assignment, Masking: Open Label
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