Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Menopause. Basic parameters: 45 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other No intervention
this is an observational study
Primary outcome measures
- MSNA- Burst frequency [Time frame: up to 5 years]
- MSNA- Burst incidence [Time frame: up to 5 years]
- MSNA- total activity [Time frame: up to 5 years]
Secondary outcome measures (3)
- cardiovagal baroreflex sensitivity: ms/mmHg [Time frame: up to 5 years]
- sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg [Time frame: up to 5 years]
- vascular conductance (mL/100mL tissue/min/mmHg) [Time frame: up to 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06490146 · PT-2024-32769