Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

NCT ID: NCT06490146

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-08-21

Brief Summary

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.

Conditions

Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

premenopausal women without vasomotor symptoms (VMS)

No intervention

Intervention Type: OTHER

this is an observational study

Interventions

No intervention

this is an observational study

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manda Keller-Ross

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emma Lee, PhD

Role: CONTACT

menopause@umn.edu

612-301-8617

Facility Contacts

Emma Lee

Role: primary

menopause@umn.edu

Other Identifiers

PT-2024-32769

Identifier Type: -

Identifier Source: org_study_id