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NCT Number: NCT06490146

Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

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.

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Key information

Conditions

Menopause

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Emma Lee

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

this is an observational study

Primary outcomes

  1. MSNA- Burst frequency

    Time frame: up to 5 years

    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.

  2. MSNA- Burst incidence

    Time frame: up to 5 years

    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.

  3. MSNA- total activity

    Time frame: up to 5 years

    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.

Secondary outcomes

  1. cardiovagal baroreflex sensitivity: ms/mmHg

    Time frame: up to 5 years

    Cardiovagal baroreflex is estimated by responses in the R-R interval of the ECG to changes in systolic pressure.

    Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

  2. sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg

    Time frame: up to 5 years

    Sympathetic baroreflex is estimated by responses in MSNA to changes in diastolic pressure.

    Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

  3. vascular conductance (mL/100mL tissue/min/mmHg)

    Time frame: up to 5 years

    vascular conductance via venous occlusion plethysmography will be quantified by FBF/mean arterial pressure

    Participants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Lee, PhD

CONTACT

[email protected]

612-301-8617

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 8, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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