Metabolic Effects of Steroids in Obese Men

Not Applicable

• Conditions: Obesity; Insulin Resistance
• Interventions: Drug: Anastrazole; Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist

• Registration Number: NCT00983554
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2009-05
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-24
• Study Completion: 2009-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-15
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anastrazole and Testosterone	Anastrazole	-
Anastrazole and Testosterone	Testosterone	-
Anastrazole and Testosterone	Dutasteride	-
Anastrazole and Testosterone	GnRH antagonist	-
Dutasteride and Testosterone	Testosterone	-
Dutasteride and Testosterone	GnRH antagonist	-
Testosterone	GnRH antagonist	-
Dutasteride and Testosterone	Dutasteride	-
Testosterone	Testosterone	-
Testosterone	Dutasteride	-

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	14 weeks

Secondary Outcome Measures

Name	Time	Method
body composition	14 weeks
lipid profile	14 weeks

Trial Locations

Locations (2)

University of California, San Diego; 🇺🇸 San Diego, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States