Hypogonadism in Young Men With Type 2 Diabetes

Launched by STATE UNIVERSITY OF NEW YORK AT BUFFALO · Jun 30, 2010

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility 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