Clinical trial NCT06490146: Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
Official title: Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopause
Keywords: blood pressure
perimenopause
vascular
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: MSNA- Burst frequency
timeFrame: up to 12 months
measure: MSNA- Burst incidence
timeFrame: up to 12 months
measure: MSNA- total activity
timeFrame: up to 12 months
Secondary outcomes:
measure: cardiovagal baroreflex sensitivity: ms/mmHg
timeFrame: up to 12 months
measure: sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg
timeFrame: up to 12 months
measure: vascular conductance (mL/100mL tissue/min/mmHg)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Manda Keller-Ross
role: PRINCIPAL_INVESTIGATOR
References: