Aging Clinical Trial
Official title:
Metabolic Effects of Androgenicity in Aging Men and Women
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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