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Metabolic Effects of Steroids in Obese Men

NCT00983554 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2011-03-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Anastrazole

Arimidex 1mg daily

DRUG

Testosterone

Testim 10g daily

DRUG

Dutasteride

Avodart 2.5mg daily

DRUG

GnRH antagonist

Acyline 300 µg/kg subcutaneous injections every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Karen L Herbst, PhD, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
51 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-05-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983554 on ClinicalTrials.gov