Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .

Detailed Description
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The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels

Official Title
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Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study

Conditions
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Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Intervention / Treatment
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* Drug: androgel
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males with age 30-60 years inclusive. PSA < 2.6 ng/ml or < 3.75 ng/ml with a negative prostate biopsy in the last 6 months. IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study Exclusion Criteria: Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c >10%; h/o prostate carcinoma; Hepatic disease (transaminase > 3 times normal) or cirrhosis; Renal impairment (serum creatinine > 1.5); HIV or Hepatitis C positive status; Participation in any other concurrent clinical trial; Any other life-threatening, non-cardiac disease; Use of over the counter health supplements which contain androgens; Use of an investigational agent or therapeutic regimen within 30 days of study. Use of testosterone in the past Hematocrit > 50%.

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: androgel<br>androgel | Drug: androgel<br>* androgel 1%<br>|
| Placebo Comparator: placebo<br>placebo gel | Drug: placebo<br>* placebo<br>* Other names: placebo gel;|
| No Intervention: no treatment<br>eugonadal comparison arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima media thickness | carotid intima media thickness | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | assessed by brachial artery Flow mediated dilatation (FMD%) | 2 years |