Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 2
Treatments androgel, androgel 10g, placebo
Phase phase 4
Sponsor Kaleida Health
Collaborator Solvay Pharmaceuticals
Start date July 2006
End date June 2013
Trial size 36 participants
Trial identifier NCT00350701, 1911

Summary

This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose diagnostic
Arm
(Experimental)
androgel 5g
androgel androgel
androgel 5g
(Experimental)
androgel 10g
androgel 10g androgel
androgel 10g
(Placebo Comparator)
placebo
placebo placebo
placebo

Primary Outcomes

Measure
To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks.
time frame: 8 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Kaleida Health.