Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

University of Minnesota (UMN)

Status

Enrolling

Conditions

Menopause

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06490146

PT-2024-32769

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

45 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.