Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
NCT ID: NCT04439370
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2019-10-01
2026-12-30
Brief Summary
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Detailed Description
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Aim Two: Determine mechanisms driving autonomic dysregulation of BP in older menopausal women. Because older age contributes to risk of CVD, it is imperative to assess the long-term effects of premature and early menopause in older (≥50 yr) women. To determine the impact of the premature loss of sex hormones on cardiovascular physiology, women whom have lived without functioning ovaries for \>10 yr will be compared to age-matched women who entered menopause at a typical age. The primary hypothesis is that resting sympathetic activity is greater and baroreflex function is attenuated in women who experience premature or early menopause compared with typically-aged menopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early compared with typically-aged menopausal women when the sympathetic nervous system is challenged with a stressor.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aim 1: Postmenopausal Women
Participants in this group are postmenopausal women.
Microneurography to measure muscle sympathetic nerve activity (MSNA)
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testing
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory Maneuvers
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood tests
Serum FSH, estrogen, progesterone, and testosterone will be measured
Aim 1: Premenopausal Women
Participants in this group are premenopausal women.
Microneurography to measure muscle sympathetic nerve activity (MSNA)
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testing
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory Maneuvers
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood tests
Serum FSH, estrogen, progesterone, and testosterone will be measured
Aim 2: Premature/Early Menopause
Participants in this group women who experienced premature or early menopause.
Microneurography to measure muscle sympathetic nerve activity (MSNA)
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testing
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory Maneuvers
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood tests
Serum FSH, estrogen, progesterone, and testosterone will be measured
Aim 2: Typical-Age Menopause
Participants in this group are women who experienced menopause at a typical age.
Microneurography to measure muscle sympathetic nerve activity (MSNA)
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testing
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory Maneuvers
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood tests
Serum FSH, estrogen, progesterone, and testosterone will be measured
Interventions
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Microneurography to measure muscle sympathetic nerve activity (MSNA)
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testing
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory Maneuvers
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood tests
Serum FSH, estrogen, progesterone, and testosterone will be measured
Eligibility Criteria
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Inclusion Criteria
* Premenopausal 35-49 years of age
* Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
* Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of \>30 mIU/mL
Exclusion Criteria
* Are diabetic or asthmatic
* Have diagnosed significant carotid stenosis
* Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
* Have existing metabolic or endocrine abnormities
* Take any heart/blood pressure medications that are determined to interfere with study outcomes
* IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
* Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
* Are pregnant or breastfeeding
35 Years
70 Years
FEMALE
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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PT-2018-27097
Identifier Type: -
Identifier Source: org_study_id
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