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Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
NCT04439370 · University of Minnesota
In plain English
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About this study
Aim One: Determine mechanisms driving autonomic dysregulation of blood pressure (BP) in premature and early menopausal women. Because sympathetic activity and baroreflex function are important contributors for autonomic support of BP regulation, these two mechanisms will be assessed in premature and early menopausal women who are ≤49 yr old. To specifically identify the influence of menopause, these women will be compared to age-matched premenopausal women. The primary hypothesis is that there is greater resting sympathetic activity and blunted baroreflex function in premature and early menopausal women compared with age-matched premenopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early menopausal compared with age-matched premenopausal women when the sympathetic nervous system is challenged with a stressor.
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.
Eligibility criteria
Inclusion Criteria:
* Aged 35-49 or 50-70 years of age who experienced premature (\<40) or early (≤45) menopause
* 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:
* Current nicotine/tobacco use within the past six months
* 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
Study design
Enrollment target: 160 participants
Age groups: adult, older_adult
Timeline
Starts: 2019-10-01
Estimated completion: 2026-12-30
Last updated: 2026-01-08
Interventions
Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic Test: Baroreflex sensitivity testingDiagnostic Test: Sympathoexcitatory ManeuversDiagnostic Test: Blood tests
Primary outcomes
- • Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute) (3 hours)
- • Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats) (3 hours)
- • Cardiac baroreflex sensitivity (3 hours)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactManda Keller-Ross, PhD, DPT, PT · contact · kell0529@umn.edu · 612-625-3175
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States