Aging Clinical Trial
Official title:
Influence of Hormone Replacement on Neural Cardiovascular Control in Postmenopausal Women
Verified date | September 2016 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Older women have an exaggerated increase in blood pressure during exercise. However, the reasons for this are unclear. It is important to investigate this phenomenon because a greater blood pressure response to exercise has been associated with an increased risk of stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is the profound change in hormone levels (i.e. estrogen and progesterone) associated with menopause. The influence of changes in estrogen and progesterone levels on the cardiovascular responses to exercise is poorly understood. However, it has been suggested that these hormones might change the responsiveness of the cardiovascular system. Possible mechanisms that could account for these changes are the arterial baroreflex and feedback from the exercising muscle (known as the exercise pressor reflex), both of which are known to powerfully modulate blood pressure during exercise. However, to date, few human studies have thoroughly examined the influence of changes in hormone levels on baroreflex function during exercise or the exercise pressor reflex in older women. As such, the purpose of this research project is to assess baroreflex function and the exercise pressor reflex in older women after transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.
Status | Terminated |
Enrollment | 118 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - We plan to study female subjects of all ethnic backgrounds ranging in age from 18 to 80 years. Only healthy, normotensive individuals not taking medications will be included in this study. - All postmenopausal women will be at least 4 years post menopause to avoid the potential for perimenopausal interference with study results Exclusion Criteria: - Active cardiopulmonary disease - Hypertension - Diabetes - Chronic Obstructive Pulmonary Disease with concurrent daily use of inhalers. - Known liver disease - Peripheral neuropathy - Chronic Kidney disease - Pregnant women - Any of the following contraindications to estrogen usage will cause exclusion: - Personal or 1st degree relative (mother, sister, daughter) history of breast, ovarian, or uterine cancer - Vaginal bleeding; - Current thrombophlebitis or venous thromboembolic disorders including deep vein thrombosis or pulmonary embolus; - Arterial thromboembolic disease such as stroke or myocardial infarction - Migraine headaches - Any previous intolerance to estrogen supplementation. - Women who have smoked during the one-year period prior to enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in carotid baroreflex sensitivity (bpm/mmHg) | Carotid baroreflex sensitivity will be measured using the application of neck pressure and neck suction. Briefly, a variable neck pressure collar will be placed around the anterior two thirds of the neck to change carotid sinus transmural pressure. | Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo. | |
Primary | Change in exercise pressor reflex responsiveness (mean blood pressure response (mmHg) and muscle sympathetic nerve activity response (burst frequency) during post handgrip ischemia.) | To estimate exercise pressor reflex responsiveness changes in blood pressure and muscle sympathetic nerve activity from rest to during a period of post handgrip ischemia will be used. | Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo. |
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