RECRUITING

Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and/or focused on older, postmenopausal females . The influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.

Official Title

Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

Quick Facts

Study Start:2025-04-01
Study Completion:2030-08-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06490146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * age 45-55 years
  3. * premenopausal
  4. * not using any medications determined to affect autonomic function
  5. * eumenorrheic
  6. * not planning to become pregnant for the duration of participation in the study
  7. * English-speaking, literate, willing and able to provide informed consent.
  1. * Diabetes
  2. * pregnant or breastfeeding
  3. * cardiac or pulmonary disorders
  4. * severe obesity (body mass index \[BMI\] ≥ 40 kg/m 2 )
  5. * hypertension
  6. * obstructive sleep apnea
  7. * current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones
  8. * report of nicotine/tobacco use in the last six months, report of current alcohol abuse,
  9. * history of treatment with chemotherapy/radiation
  10. * coagulopathy disorders and/or use of anticoagulant medications, and current use of anxiolytics and/or antidepressants.

Contacts and Locations

Study Contact

Emma Lee, PhD
CONTACT
612-301-8617
menopause@umn.edu

Principal Investigator

Manda Keller-Ross
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Manda Keller-Ross, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2030-08-21

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2030-08-21

Terms related to this study

Keywords Provided by Researchers

  • blood pressure
  • perimenopause
  • vascular

Additional Relevant MeSH Terms

  • Menopause