Status:
TERMINATED
Hypogonadism in Young Men With Type 2 Diabetes
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
American Diabetes Association
Conditions:
Hypogonadotropic Hypogonadism
Type 2 Diabetes
Eligibility:
MALE
18-40 years
Phase:
PHASE2
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 de...
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;...
Eligibility Criteria
Inclusion
- T2D Males with age 18-40 years
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01155518
Start Date
June 1 2010
End Date
December 1 2013
Last Update
October 4 2019
Active Locations (1)
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1
Millard Fillmore Gates Hospital
Buffalo, New York, United States, 14209