Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
This trial is active, not recruiting.
|Condition||diabetes mellitus type 2|
|Treatments||androgel, androgel 10g, placebo|
|Start date||July 2006|
|End date||June 2013|
|Trial size||36 participants|
|Trial identifier||NCT00350701, 1911|
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks.
time frame: 8 weeks
Comparison of relative change from baseline in inflammatory mediators and reactive oxygen species generation after either AndroGel or placebo at week 8.
time frame: 8 weeks
Male participants from 35 years up to 75 years old.
Inclusion Criteria: - 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 Criteria: - 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.
|Official title||Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism|
|Principal investigator||Paresh Dandona, MD|
|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. This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy. This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.|
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