Metabolic Effects of Androgenicity in Aging Men and Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | January 2005 |
| End Date: | July 2016 |
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.
The investigators 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. Prostate Specific Antigen > 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.
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.
The investigators 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. Prostate Specific Antigen > 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.
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 Los Angeles VA and University of California, Los Angeles in
Los Angeles, California
Exclusion Criteria:
- any clinically significant abnormalities detected on screening physical exam or
laboratory testing (e.g. prostate specific antigen > 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
We found this trial at
1
site
Click here to add this to my saved trials
