RecruitingNCT04439370

Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women


Sponsor

University of Minnesota

Enrollment

160 participants

Start Date

Oct 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Specifically, aim one will determine mechanisms driving autonomic dysregulation of BP in premature and early menopausal women and aim two will determine mechanisms driving autonomic dysregulation of BP in older menopausal women. The study design outlined below will permit testing of aim one and aim two.


Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

Interventions

DIAGNOSTIC_TESTMicroneurography to measure muscle sympathetic nerve activity (MSNA)

Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves

DIAGNOSTIC_TESTBaroreflex 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.

DIAGNOSTIC_TESTSympathoexcitatory Maneuvers

Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed

DIAGNOSTIC_TESTBlood tests

Serum FSH, estrogen, progesterone, and testosterone will be measured


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT04439370


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