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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
  Purpose

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.


Condition Intervention
Hypogonadism
 Drug: GnRH antagonist (Acyline)

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GnRH antagonist (Acyline)
    3 Subcutaneous injections (300 mcg/kg) over 36 days
    Other Name: IND # 62,621
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470990

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02143
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Investigators
Principal Investigator: Frances J Hayes, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Frances J. Hayes, MD, Massachusetts General Hospital, Boston MA
ClinicalTrials.gov Identifier: NCT00470990     History of Changes
Other Study ID Numbers: 2002-P-001445 (completed)
Study First Received: May 7, 2007
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
IHH
Kallmann syndrome
hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Insulin Resistance
Gonadal Disorders
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
 Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 16, 2013