Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men

Completed · Not applicable

Conditions studied: Hypogonadism

In brief

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.

Key facts

Study ID

NCT00470990

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

40

Starts

2002-10-01

Expected to finish

2008-06-01

Last updated by the study team

2011-04-20

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy men:
• Good general health,
• Normotensive,
• Normal testosterone levels,
• No medications known to influence glucose homeostasis or testosterone levels
• IHH men:
• Good general health;
• Normal thyroid, adrenal, and GH axes;
• Normal prolactin levels;
• No abnormalities on imaging of the hypothalamic-pituitary region;
• No medications known to influence glucose homeostasis;
• Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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