Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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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

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Intervention Type DRUG

Other Intervention Names

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androgel

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No