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

NCT00470990 | Completed DMC

• 1 other identifier: 2002-P-001445 (completed)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Keywords

IHH; Kallmann syndrome; hypogonadism

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Secondary Outcomes (1)

• body composition

  2 timepoints: with a normal serum testsoterone and in a castrate state of low serum testoserone

Interventions

GnRH antagonist (Acyline) DRUG

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

Also known as: IND # 62,621

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• American Diabetes Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02143, United States

Location

MeSH Terms

Conditions

Hypogonadism; Kallmann Syndrome

Interventions

acyline

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Frances J Hayes, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 8, 2007
• Study Start: October 1, 2002
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

US (1)