Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Phase 4

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: androgel 10g; Drug: placebo; Drug: androgel

• Registration Number: NCT00350701
• Lead Sponsor: University at Buffalo

Brief 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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-10
• Study First Submitted QC: 2006-07-10
• Study First Posted: 2006-07-11
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Results First Submitted: 2019-11-07
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Results First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
androgel 10g	androgel 10g	androgel 10g
placebo	placebo	placebo
androgel 5g	androgel	androgel 5g

Primary Outcome Measures

Name	Time	Method
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo	8 weeks	To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups

Secondary Outcome Measures

Name	Time	Method
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo	8 weeks	Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone	8 week	To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks.

Trial Locations

Locations (1)

Diabetes-Endocrinology Center of Western NY, 115 flint road; 🇺🇸 Buffalo, New York, United States