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Metabolic Effects of Androgenicity in Aging Men and Women
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, November 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680797
  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

Drug Information available for: Insulin Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate
U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
1: Experimental
+Testosterone, +Estrogen
Drug: Testosterone
Testosterone gel
Drug: Estrogen
Estrogen patch
2: Experimental
+Testosterone, -Estrogen
Drug: Testosterone
Testosterone gel
3: Experimental
-Testosterone, +Estrogen
Drug: Estrogen
Estrogen patch
4: No Intervention
-Testosterone, -Estrogen

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680797

Contacts
Contact: Cathy Lee, PhD cathy.lee2@va.gov
Contact: Gian Greenberg (310) 268-4110 giannyg@ucla.edu

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Cathy Lee, PhD VA Greater Los Angeles Healthcare System, West LA
  More Information

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

Keywords provided by Department of Veterans Affairs:
Aging
Hormones
Insulin resistance

Study placed in the following topic categories:
Hyperinsulinism
Testosterone
Metabolic Diseases
Methyltestosterone
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 14, 2009