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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +T +E | Experimental | +Testosterone, +Estrogen |
|
| +T -E | Experimental | +Testosterone, -Estrogen |
|
| -T +E | Experimental | -Testosterone, +Estrogen |
|
| -T -E | No Intervention | -Testosterone, -Estrogen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testosterone gel |
| |
| Estrogen |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | As measured by change in insulin levels pre- and post-hormone changes | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy C Lee, PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
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Recruitment methods included flyers and advertisement in local newspapers. Healthy Veteran and community participants who responded to to advertisement were screened by telephone for exclusion criteria. If no exclusion criteria were reported, participants were scheduled for a screening history and physical.
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| ID | Title | Description |
|---|---|---|
| FG000 | +T +E | +Testosterone, +Estrogen Testosterone: Testosterone gel Estrogen: Estrogen patch |
| FG001 | +T -E | +Testosterone, -Estrogen Testosterone: Testosterone gel |
| FG002 | -T +E | -Testosterone, +Estrogen Estrogen: Estrogen patch |
| FG003 | -T -E | -Testosterone, -Estrogen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | +T +E | +Testosterone, +Estrogen Testosterone: Testosterone gel Estrogen: Estrogen patch |
| BG001 | +T -E | +Testosterone, -Estrogen Testosterone: Testosterone gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity | As measured by change in insulin levels pre- and post-hormone changes | Two participants had missing values post-intervention therefore number of participants analyzed total 31. | Posted | Mean | Standard Deviation | micro International Units/mL | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | +T +E | +Testosterone, +Estrogen Testosterone: Testosterone gel Estrogen: Estrogen patch |
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Small sample size may limit generalizability of these results. Follow-up studies are being conducted to further evaluate these results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cathy Lee | VA Greater Los Angeles | 310-478-3711 | 42627 | cathy.lee2@va.gov |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D004967 | Estrogens |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Estrogen patch |
|
| BG002 | -T +E | -Testosterone, +Estrogen Estrogen: Estrogen patch |
| BG003 | -T -E | -Testosterone, -Estrogen |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body-Mass-Index | Mean | Standard Deviation | kilogram/meter squared |
|
| Total testosterone | Mean | Standard Deviation | nanogram/deciliter |
|
-Testosterone, +Estrogen Estrogen: Estrogen patch |
| OG003 | -T -E | -Testosterone, -Estrogen |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | +T -E | +Testosterone, -Estrogen Testosterone: Testosterone gel | 0 | 8 | 0 | 8 |
| EG002 | -T +E | -Testosterone, +Estrogen Estrogen: Estrogen patch | 0 | 8 | 0 | 8 |
| EG003 | -T -E | -Testosterone, -Estrogen | 0 | 8 | 0 | 8 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |