Hypogonadism in Young Men With Type 2 Diabetes

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypogonadotropic Hypogonadism, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01155518

Run by

State University of New York at Buffalo

People needed

5

Starts

2010-06-01

Expected to finish

2013-12-01

Last updated by the study team

2019-10-04

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• T2D Males with age 18-40 years

You may not qualify if…

• 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

Where it is running

• Millard Fillmore Gates Hospital — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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