Metabolic Effects of Steroids in Obese Men

March 15, 2011 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition
Time Frame: 14 weeks
14 weeks
lipid profile
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Karen L Herbst, PhD, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK65038 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Anastrazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe