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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00680797 |
The goal of this research study is to study the effect of testosterone or estrogen on blood sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of the hormone insulin or an insensitivity to it resulting in problems with blood sugar control and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by older adults on insulin and body composition is not well understood. In this study, the role of testosterone and estrogen on your ability to control blood sugar and your body composition will be assessed.
We plan to study 60 subjects. All of these subjects will be healthy older men between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are screened who have any clinically significant abnormalities detected on their screening physical exam or laboratory testing (e.g. PSA > 4), who have a history of prostate cancer, polycythemia, or who cannot take testosterone will not be included.
If a subject is eligible to participate after initial screening, that subject will take medications to adjust their hormone levels and have tests performed that measure insulin sensitivity and adiposity before and after these hormone medications. The outcomes that will be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.
Condition | Intervention |
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Aging Insulin Resistance |
Drug: Testosterone Drug: Estrogen |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Metabolic Effects of Androgenicity in Aging Men and Women |
Estimated Enrollment: | 60 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
+Testosterone, +Estrogen
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Drug: Testosterone
Testosterone gel
Drug: Estrogen
Estrogen patch
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2: Experimental
+Testosterone, -Estrogen
|
Drug: Testosterone
Testosterone gel
|
3: Experimental
-Testosterone, +Estrogen
|
Drug: Estrogen
Estrogen patch
|
4: No Intervention
-Testosterone, -Estrogen
|
Ages Eligible for Study: | 60 Years to 85 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathy Lee, PhD | cathy.lee2@va.gov | |
Contact: Gian Greenberg | (310) 268-4110 | giannyg@ucla.edu |
United States, California | |
VA Greater Los Angeles Healthcare System, West LA | Recruiting |
West Los Angeles, California, United States, 90073 | |
Contact: Cathy Lee, PhD cathy.lee2@va.gov | |
Principal Investigator: Cathy Lee, PhD |
Principal Investigator: | Cathy Lee, PhD | VA Greater Los Angeles Healthcare System, West LA |
Responsible Party: | Department of Veterans Affairs ( Lee, Cathy - Principal Investigator ) |
Study ID Numbers: | ARCD-034-04F |
Study First Received: | May 8, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00680797 |
Health Authority: | United States: Federal Government |
Aging Hormones Insulin resistance |
Hyperinsulinism Testosterone Metabolic Diseases Methyltestosterone Insulin Resistance |
Metabolic disorder Glucose Metabolism Disorders Insulin Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |