Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Information source: Kaleida Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus Type 2
Intervention: androgel (Drug); androgel 10g (Drug); placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Kaleida Health Official(s) and/or principal investigator(s):
Paresh Dandona, MD, Principal Investigator, Affiliation: Kaleida Health/Diabetes Endocrinology Center of WNY
Summary
This is to study the effect of replacing testosterone on different inflammatory cells in
type 2 diabetics with low testosterone levels.
Clinical Details
Official title: Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Primary outcome: To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks.
Secondary outcome: Comparison of relative change from baseline in inflammatory mediators and reactive oxygen species generation after either AndroGel or placebo at week 8.
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.
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Diabetes-Endocrinology Center of Western NY, 115 flint road, Buffalo, New York 14221, United States
Additional Information
Starting date: July 2006
Last updated: December 17, 2012
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