Hypogonadism in Young Men With Type 2 Diabetes

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: American Diabetes Association
• Treatments: Clomiphene; Enclomiphene; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate; Zuclomiphene

Criteria

Inclusion Criteria:

• T2D Males with age 18-40 years

Exclusion Criteria:

1. planning to have children in the next one year

2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;

3. PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma

4. Hemoglobin A1c > 8%

5. Hematocrit > 50%

6. History of obstructive sleep apnea

7. Congestive heart failure

8. Use of thiazolidinediones or exenatide

9. currently suffering from depression, with or without treatment

10. history of severe depression in the past which needed hospitalization

11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition

12. Coronary event or procedure in the previous 6 months

13. Hepatic disease (transaminase > 3 times normal) or cirrhosis

14. Renal impairment (serum creatinine > 1.5)

15. HIV or Hepatitis C positive status

16. Participation in any other concurrent clinical trial