Understanding how menopause affects heart and blood vessel function
Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
University of Minnesota · NCT06490146
This study looks at how going through menopause affects heart and blood vessel function in women aged 45-55.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 45 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Minnesota (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06490146 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of the menopause transition on autonomic and vascular function in midlife females aged 45-55. It will longitudinally track 80 participants to assess changes in these functions during this critical period. The study is motivated by previous findings that suggest postmenopausal women exhibit heightened sympathetic neural reactivity compared to their male counterparts and younger females. By focusing on the menopause transition, the study seeks to fill a gap in existing literature regarding its effects on autonomic function.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy females aged 45-55 who are premenopausal and not using medications that affect autonomic function.
Not a fit: Patients with diabetes, hypertension, or those currently using heart or blood pressure medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved management of cardiovascular health in menopausal women.
How similar studies have performed: While there is limited literature specifically addressing the menopause transition's impact on autonomic function, previous studies have shown significant findings related to postmenopausal health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * age 45-55 years * premenopausal * not using any medications determined to affect autonomic function * eumenorrheic * not planning to become pregnant for the duration of participation in the study * English-speaking, literate, willing and able to provide informed consent. Exclusion Criteria: * Diabetes * pregnant or breastfeeding * cardiac or pulmonary disorders * severe obesity (body mass index \[BMI\] ≥ 40 kg/m 2 ) * hypertension * obstructive sleep apnea * current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones * report of nicotine/tobacco use in the last six months, report of current alcohol abuse, * history of treatment with chemotherapy/radiation * coagulopathy disorders and/or use of anticoagulant medications, and current use of anxiolytics and/or antidepressants.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Manda Keller-Ross — University of Minnesota
- Study coordinator: Emma Lee, PhD
- Email: menopause@umn.edu
- Phone: 612-301-8617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause, blood pressure, perimenopause, vascular