NCT01155518

Hypogonadism in Young Men With Type 2 Diabetes

Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.

Detailed description

This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.

Conditions

• Hypogonadotropic Hypogonadism
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	testosterone	intramuscular every 2 weeks
DRUG	clomiphene	thrice a week
DRUG	placebo	intramuscular saline injections every 2 weeks
DRUG	placebo	oral

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-07-01
• Last updated: 2019-10-04
• Results posted: 2019-10-04

Locations

1 site across 1 country: United States