Hypogonadism in Young Men With Type 2 Diabetes

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

planning to have children in the next one year
Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
Hemoglobin A1c > 8%
Hematocrit > 50%
History of obstructive sleep apnea
Congestive heart failure
Use of thiazolidinediones or exenatide
currently suffering from depression, with or without treatment
history of severe depression in the past which needed hospitalization
currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Coronary event or procedure in the previous 6 months
Hepatic disease (transaminase > 3 times normal) or cirrhosis
Renal impairment (serum creatinine > 1.5)
HIV or Hepatitis C positive status
Participation in any other concurrent clinical trial

Arm && Interventions

Group	Intervention	Description
placebo for testosterone	placebo	placebo for testosterone arm
testosterone	testosterone	intramuscular injections every 2 weeks
placebo for clomiphene	placebo	oral placebo for clomiphene arm
clomiphene	clomiphene	oral drug thrice a week

Primary Outcome Measures

Name	Time	Method
Insulin Resistance	6 months	To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.

Secondary Outcome Measures