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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) American Diabetes Association |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00470990 |
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 |
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Hypogonadism |
Drug: GnRH antagonist (Acyline) |
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 |
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) |
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:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy men:
Good general health,
IHH men:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02143 |
Principal Investigator: | Frances J Hayes, MD | Massachusetts General Hospital |
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 |
Health Authority: | United States: Food and Drug Administration |
IHH Kallmann syndrome hypogonadism |
Testosterone Hypogonadism Gonadal Disorders Endocrine System Diseases Septo-optic dysplasia Kallmann Syndrome |
Methyltestosterone Endocrinopathy Insulin Testosterone 17 beta-cypionate Septo-Optic Dysplasia |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |