What this study is
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.
What's being tested
- Microneurography to measure muscle sympathetic nerve activity (MSNA)
Intervention · DIAGNOSTIC TEST
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
- Baroreflex sensitivity testing
Intervention · DIAGNOSTIC TEST
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
Intervention · DIAGNOSTIC TEST
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
- Blood tests
Intervention · DIAGNOSTIC TEST
Serum FSH, estrogen, progesterone, and testosterone will be measured
Study details
- Sponsor
- University of Minnesota
- Conditions
- Hypertension · Menopause, Premature · Menopause · Blood Pressure
- Enrolling
- 160 people
- Starts
- 2019-10-01
- Est. completion
- 2026-12-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 35 Years – 70 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Minnesota
Minneapolis, Minnesota, United States
- Manda Keller-Ross, PhD, DPT, PT · Contact612-625-3175kell0529@umn.edu
Recruiting
Study team
Sponsor
University of Minnesota
Study ID PT-2018-27097
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.