Official Title: “Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism”

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

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Study Primary Completion Date: June 2010

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.

Intervention(s) in this Clinical Trial

• Drug: androgel
  • androgel 5g
• Drug: androgel 10g
  • androgel 10g
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: androgel 5g
  • androgel 5g
• Experimental: androgel 10g
  • androgel 10g
• Placebo Comparator: placebo
  • placebo

Primary Measures

• To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kaleida Health

Overall Clinical Trial Officials and Contacts

Paresh Dandona, MD Principal Investigator Kaleida Health/Diabetes Endocrinology Center of WNY  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350701

Study ID Number: 1911

ClinicalTrials.gov Identifier: NCT00350701

Health Authority: United States: Institutional Review Board