Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
ConditionMenopause
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-55
SponsorUniversity of Minnesota
About this trial
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
This trial accepts healthy volunteersQualifiers
Female
age 45-55 years
premenopausal
not using any medications determined to affect autonomic function
Disqualifiers
Diabetes
pregnant or breastfeeding
cardiac or pulmonary disorders
severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionthis is an observational study
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 5 years2
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.
Time frame
up to 5 years3
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.
Time frame
up to 5 yearsSecondary outcomes
1
cardiovagal baroreflex sensitivity: ms/mmHg
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.
Time frame
up to 5 years2
sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg
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.
Time frame
up to 5 years3
vascular conductance (mL/100mL tissue/min/mmHg)
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.
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov