Metabolic Effects of Steroids in Obese Men

National Institutes of Health (NIH)

Status: Unknown

Conditions: Insulin Resistance; Obesity

Treatments: Drug: Testosterone; Drug: Anastrazole; Drug: Dutasteride; Drug: GnRH antagonist

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00983554

DK65038 (completed)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: Male

Ages: 24 to 51 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 4 patient groups

Placebo

No Intervention group

Anastrazole and Testosterone

Experimental group

Treatment:

Drug: Testosterone

Drug: Anastrazole

Drug: Dutasteride

Drug: GnRH antagonist

Dutasteride and Testosterone

Experimental group

Treatment:

Drug: Testosterone

Drug: Dutasteride

Drug: GnRH antagonist

Testosterone

Experimental group

Treatment:

Drug: Testosterone

Drug: Dutasteride

Drug: GnRH antagonist