Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) American Diabetes Association
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00470990

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)

Genetics Home Reference related topics: Kallmann syndrome

MedlinePlus related topics: Diabetes

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Insulin Acyline Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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

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:

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

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.

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:	Massachusetts General Hospital, Boston MA ( Frances J. Hayes, MD )
Study ID Numbers:	2002-P-001445
Study First Received:	May 7, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00470990 History of Changes
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

Study placed in the following topic categories:

Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Kallmann Syndrome
Methyltestosterone
Hormones
Insulin

Testosterone 17 beta-cypionate
Testosterone
Hypogonadism
Septo-optic Dysplasia
Endocrinopathy
Septo-Optic Dysplasia
Androgens

Additional relevant MeSH terms:

Testosterone
Hypogonadism
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Endocrine System Diseases
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on May 07, 2009