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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source | |
| R56HL114073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. However, there are differences between men and women in their response to exercise. In older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. The purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. In this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo patch - placebo tablets | Placebo Comparator | Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit. |
|
| Placebo patch - Resveratrol tablets | Experimental | Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit. |
|
| Climara patch - placebo tablets | Active Comparator | Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Climara | Drug |
|
| |
| Placebo patch |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point | Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point. | Up to 2 hours post-exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Gene and Protein Expression in Peripheral Blood Mononuclear Cells | No gene and protein data were analyzed. | baseline, 1-2 hours post-exercise |
| Change in Nitrate/Nitrite Levels | Measure of nitric oxide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerrie L Moreau, PhD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
7 participants did not qualify to participate in the study after consent/enrollment.
Healthy women ages 50-70 years, at least 1 year beyond menopause and free of overt cardiovascular or chronic diseases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Visit 1 Placebo - Visit 2 Estrogen - Visit 3 Resveratrol | Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Placebo tablet: Placebo tablets designed to match active resveratrol tablets. Visit 2 Estrogen: Climara patch was worn two days prior to and during the exercise visit. Placebo tablet:Placebo tablets designed to match active resveratrol tablets. Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit. |
| FG001 | Visit 1 Resveratrol - Visit 2 Placebo - Visit 3 Estrogen | Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit. Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Placebo tablet: Placebo tablets designed to match active resveratrol tablets. Visit 3 Estrogen: Climara patch was worn two days prior to and during the exercise visit. Placebo tablet:Placebo tablets designed to match active resveratrol tablets. |
| FG002 | Visit 1 Estrogen - Visit 2 Resveratrol - Visit 3 Placebo | Visit 1 Estrogen: Climara patch was worn two days prior to and during the exercise visit. Placebo tablet:Placebo tablets designed to match active resveratrol tablets. Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit. Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit. Placebo tablet: Placebo tablets designed to match active resveratrol tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point | Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point. | Images were considered invalid and removed from analysis if the vascular boundaries were not able to be identified. | Posted | Mean | Standard Error | Percent Change | Up to 2 hours post-exercise |
|
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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 | Placebo Patch - Placebo Tablets | Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit. Placebo patch: Placebo patch designed to match active Climara patches. Placebo: Placebo tablets designed to match active resveratrol tablets. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerrie Moreau | University of Colorado Anschutz Medical Campus | 303-724-1914 | kerrie.moreau@cuanschutz.edu |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
Placebo patch designed to match active Climara patches. |
|
| Resveratrol | Dietary Supplement |
|
| Placebo | Dietary Supplement | Placebo tablets designed to match active resveratrol tablets. |
|
| baseline, 1-2 hrs post-exercise |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Placebo Patch - Resveratrol Tablets |
Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit. Placebo patch: Placebo patch designed to match active Climara patches. Resveratrol |
| OG002 | Climara Patch - Placebo Tablets | Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit. Climara Placebo: Placebo tablets designed to match active resveratrol tablets. |
|
|
| Secondary | Gene and Protein Expression in Peripheral Blood Mononuclear Cells | No gene and protein data were analyzed. | No data were collected for this outcome measure. | Posted | baseline, 1-2 hours post-exercise |
|
|
| Secondary | Change in Nitrate/Nitrite Levels | Measure of nitric oxide | Posted | Mean | Standard Deviation | micromolar | baseline, 1-2 hrs post-exercise |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Patch - Resveratrol Tablets | Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit. Placebo patch: Placebo patch designed to match active Climara patches. Resveratrol | 0 | 15 | 0 | 15 |
| EG002 | Climara Patch - Placebo Tablets | Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit. Climara Placebo: Placebo tablets designed to match active resveratrol tablets. | 0 | 15 | 0 | 15 |
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| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
|
| 120 min after exercise |
|