Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Study Overview
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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.

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.

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

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: androgel
* Drug: androgel 10g
* Drug: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: androgel 5g<br>androgel 5g | Drug: androgel<br>* androgel 5g<br>|
| Experimental: androgel 10g<br>androgel 10g | Drug: androgel 10g<br>* androgel 10g<br>* Other names: androgel;|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo | 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo | 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 | 8 weeks | 
| Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone | 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. | 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DM type 2, Hypogonadism, Testosterone, AndroGel