Metabolic Effects of Androgenicity in Aging Men and Women
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Purpose
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 |
|---|---|
|
Aging Insulin Resistance |
Drug: Testosterone Drug: Estrogen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Metabolic Effects of Androgenicity in Aging Men and Women |
- Insulin Sensitivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
+Testosterone, +Estrogen
|
Drug: Testosterone
Testosterone gel
Drug: Estrogen
Estrogen patch
|
|
Experimental: Arm 2
+Testosterone, -Estrogen
|
Drug: Testosterone
Testosterone gel
|
|
Experimental: Arm 3
-Testosterone, +Estrogen
|
Drug: Estrogen
Estrogen patch
|
|
No Intervention: Arm 4
-Testosterone, -Estrogen
|
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- males age 60-85 years
- non-diabetic fasting glucose and 2-hour oral glucose tolerance test (OGTT)
- overall good general medical health and signed informed consent
- willing to travel to West LA VA and UCLA in Los Angeles, CA
Exclusion Criteria:
- any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. PSA > 4)
- or other symptom or history of a significant underlying medical or psychiatric illness
- BMI < 20 or > 40
- subjects already on testosterone therapy or medications that might influence glucose regulation or hormone levels
- subjects with a history of deep venous thromboses, pulmonary embolism, breast cancer, prostate cancer, polycythemia or other contraindications to estrogen or testosterone
Contacts and Locations| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| Principal Investigator: | Cathy Lee, PhD | VA Greater Los Angeles Healthcare System, West LA |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00680797 History of Changes |
| Other Study ID Numbers: | ARCD-034-04F |
| Study First Received: | May 8, 2008 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Aging Hormones Insulin resistance |
Additional relevant MeSH terms:
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Estrogens |
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 22, 2013