Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

NCT06490146 | Recruiting

• 1 other identifier: PT-2024-32769
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

blood pressure; perimenopause; vascular

Outcome Measures

Primary Outcomes (3)

• MSNA- Burst frequency

  measured in bursts/min Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

  up to 5 years

• MSNA- Burst incidence

  measured in bursts/100 heartbeats Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

  up to 5 years

• MSNA- total activity

  Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

  up to 5 years

Secondary Outcomes (3)

• cardiovagal baroreflex sensitivity: ms/mmHg

  up to 5 years

• sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg

  up to 5 years

• vascular conductance (mL/100mL tissue/min/mmHg)

  up to 5 years

Study Arms (1)

Study group

premenopausal women without vasomotor symptoms (VMS)

Other: No intervention

Interventions

No intervention OTHER

this is an observational study

Study group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Study Officials

• Manda Keller-Ross

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Lee, PhD

CONTACT

612-301-8617; menopause@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 21, 2030
• Study Completion (Estimated): August 21, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)