Status:
TERMINATED
Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Eligibility:
MALE
31-60 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .
Detailed Description
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by com...
Eligibility Criteria
Inclusion
- Males with age 30-60 years inclusive.
- PSA \< 2.6 ng/ml or \< 3.75 ng/ml with a negative prostate biopsy in the last 6 months.
- IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study
Exclusion
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c \>10%;
- h/o prostate carcinoma;
- 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;
- Any other life-threatening, non-cardiac disease;
- Use of over the counter health supplements which contain androgens;
- Use of an investigational agent or therapeutic regimen within 30 days of study.
- Use of testosterone in the past
- Hematocrit \> 50%.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00467987
Start Date
June 1 2007
End Date
October 11 2018
Last Update
February 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes Endocrinology Research Center of WNY
Buffalo, New York, United States, 14215