This trial is active, not recruiting.

Conditions aging, insulin resistance
Treatments testosterone, estrogen
Sponsor Department of Veterans Affairs
Start date January 2005
End date December 2012
Trial size 60 participants
Trial identifier NCT00680797, ARCD-034-04F


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
+Testosterone, +Estrogen
Testosterone gel
Estrogen patch
+Testosterone, -Estrogen
Testosterone gel
-Testosterone, +Estrogen
Estrogen patch
(No Intervention)
-Testosterone, -Estrogen

Primary Outcomes

Insulin Sensitivity
time frame: 6 weeks

Eligibility Criteria

Male participants from 60 years up to 85 years old.

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

Additional Information

Official title Metabolic Effects of Androgenicity in Aging Men and Women
Principal investigator Cathy Lee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.