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

This study has been completed.

Sponsor:

Collaborator:

American Diabetes Association

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00470990

First received: May 7, 2007

Last updated: April 18, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2007

Last Updated Date

April 18, 2011

Start Date ^ICMJE

October 2002

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

insulin sensitivity [ Time Frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00470990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

body composition [ Time Frame: 2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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:

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
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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Hypogonadism

Intervention ^ICMJE

Drug: GnRH antagonist (Acyline)

3 Subcutaneous injections (300 mcg/kg) over 36 days

Other Name: IND # 62,621

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00470990

Other Study ID Numbers ^ICMJE

2002-P-001445 (completed)

Has Data Monitoring Committee

Yes

Responsible Party

Frances J. Hayes, MD, Massachusetts General Hospital, Boston MA

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

American Diabetes Association

Investigators ^ICMJE

Principal Investigator:

Frances J Hayes, MD

Massachusetts General Hospital

Information Provided By

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

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top