Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men

April 18, 2011 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect 16 million Americans. Established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. The purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. Information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. All subjects will be in good general health and 2 groups of men will be studied in this protocol:

  1. Thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone
  2. Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02143
        • Massachusetts General Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Healthy men:

Good general health,

  • Normotensive,
  • Normal testosterone levels,
  • No medications known to influence glucose homeostasis or testosterone levels

IHH men:

  • Good general health;
  • Normal thyroid, adrenal, and GH axes;
  • Normal prolactin levels;
  • No abnormalities on imaging of the hypothalamic-pituitary region;
  • No medications known to influence glucose homeostasis;
  • Must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

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

  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity
Time Frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition
Time Frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone
2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

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

American Diabetes Association

Investigators

  • Principal Investigator: Frances J Hayes, MD, Massachusetts General Hospital

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

October 1, 2002

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 8, 2007

Study Record Updates

Last Update Posted (Estimate)

April 20, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-P-001445 (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.

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