Metabolic Effects of Steroids in Obese Men

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity Insulin Resistance

Interventions

Eligibility

Sex: MALEMin age: 24 YearsMax age: 51 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of California, San Diego

San Diego, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Outcomes

Primary Outcomes

insulin sensitivity

Time frame: 14 weeks

Secondary Outcomes

body composition

Time frame: 14 weeks

lipid profile

Time frame: 14 weeks