Status:
COMPLETED
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Diabetes Mellitus Type 2
Eligibility:
MALE
35-75 years
Phase:
PHASE4
Brief Summary
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Detailed Description
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis...
Eligibility Criteria
Inclusion
- Males with age 35-75 years inclusive.
- Evidence of hypogonadism: low free testosterone.
- Type 2 Diabetes
- People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
- If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
- BP under control even if on medication.
Exclusion
- Coronary event or procedure in previous past 4 wks.
- High PSA
- H/O prostate cancer
- Hepatic or renal disease
- Participation in any other concurrent clinical trial
- Any other life- threatening , non cardiac disease.
- Uncontrolled BP
- Congestive heart failure
- High hemoglobin
- Use of investigational agent or therapeutic regimen within 30 days of study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00350701
Start Date
July 1 2006
End Date
July 1 2013
Last Update
February 10 2022
Active Locations (1)
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1
Diabetes-Endocrinology Center of Western NY, 115 flint road
Buffalo, New York, United States, 14221