Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
Recruiting · NCT04439370 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
Baroreflex sensitivity testingBlood testsMicroneurography to measure muscle sympathetic nerve activity (MSNA)Sympathoexcitatory Maneuvers
What this trial is about
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.
Who can take part
Age range
35 Years to 70 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States