NCT00350701

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: Male
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	androgel	androgel 5g
DRUG	androgel 10g	androgel 10g
DRUG	placebo	placebo

Timeline

• Start date: 2006-07-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2006-07-11
• Last updated: 2022-02-10
• Results posted: 2022-02-10

Locations

1 site across 1 country: United States