Metabolic Effects of Steroids in Obese Men

Study Overview
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Brief Summary
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Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.

Official Title
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Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Drug: Anastrazole
* Drug: Testosterone
* Drug: Dutasteride
* Drug: GnRH antagonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: free T level in the lower 25% of the normal range or below BMI ≥30kg/m2 waist circumference ≥100cm Exclusion Criteria: pituitary tumors HIV infection Klinefelter's syndrome Kallman's syndrome uncontrolled hypertension diabetes congestive heart failure chronic lung disease acute coronary syndrome PSA >4µg/L aspartate aminotransferase (AST)> 3x upper limit of normal use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance. involvement in daily resistance training or high endurance exercise alcohol or drug dependence obstructive sleep apnea

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 51 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br> | |
| Experimental: Anastrazole and Testosterone<br> | Drug: Anastrazole<br>* Arimidex 1mg daily<br>Drug: Testosterone<br>* Testim 10g daily<br>Drug: Dutasteride<br>* Avodart 2.5mg daily<br>Drug: GnRH antagonist<br>* Acyline 300 µg/kg subcutaneous injections every 2 weeks<br>|
| Experimental: Dutasteride and Testosterone<br> | Drug: Testosterone<br>* Testim 10g daily<br>Drug: Dutasteride<br>* Avodart 2.5mg daily<br>Drug: GnRH antagonist<br>* Acyline 300 µg/kg subcutaneous injections every 2 weeks<br>|
| Experimental: Testosterone<br> | Drug: Testosterone<br>* Testim 10g daily<br>Drug: Dutasteride<br>* Avodart 2.5mg daily<br>Drug: GnRH antagonist<br>* Acyline 300 µg/kg subcutaneous injections every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | 14 weeks | 
| lipid profile |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, insulin, obesity, aromatase, 5 alpha reductase