Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- MSNA- Burst incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study group
premenopausal women without vasomotor symptoms (VMS)
干预措施: No intervention (Other)
结局指标
主要结局
MSNA- Burst incidence
时间窗: up to 12 months
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.
MSNA- Burst frequency
时间窗: up to 12 months
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.
MSNA- total activity
时间窗: up to 12 months
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.
MSNA- Burst frequency
时间窗: 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.
MSNA- Burst incidence
时间窗: 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.
MSNA- total activity
时间窗: 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.
次要结局
- sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg(up to 12 months)
- vascular conductance (mL/100mL tissue/min/mmHg)(up to 12 months)
- cardiovagal baroreflex sensitivity: ms/mmHg(up to 12 months)
- cardiovagal baroreflex sensitivity: ms/mmHg(up to 5 years)
- sympathetic baroreflex sensitivity: bursts/100heartbeats/mmHg(up to 5 years)
- vascular conductance (mL/100mL tissue/min/mmHg)(up to 5 years)