Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- sympathetic nerve activity
研究概览
简要总结
The purpose of this study is to understand how changes in menopausal hormones like estradiol and follicle-stimulating hormone (FSH) impact sympathetic nervous system function. To do so, the investigators will use a medication to control the production of estradiol and FSH, and in some participants, add-back estradiol to isolate its effects. The investigators will measure sympathetic activation centrally (in the brain using MRI), peripherally in the nervous system, and also examine adrenergic receptor mediated control of vascular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Perimenopausal (based on changes in menstrual cycle)
- •Ages 40-58 years
排除标准
- •History of CVD, blood clots, stroke
- •History of Cancer
- •History of Liver or Kidney disease
- •History of Neurological disease
- •BMI>35kg/m2
- •Pregnant, planning on becoming pregnant, or breast feeding
- •Allergy to Latex
- •Use of Tobacco
- •Hysterectomy
- •Blood pressure >140/90 mmHg
- •Current or prior use of hormone replacement therapy (within 3 mo)
研究组 & 干预措施
Estrogen
干预措施: Estrogen (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
sympathetic nerve activity
时间窗: on day 6-8 of the hormone treatment
Sympathetic nerve activity will be measured using a technique called microneurography and reported as burst frequency (number of bursts per minute) and burst area (height / size of bursts).
次要结局
- BOLD fMRI(on day 6-8 of the hormone treatment)