Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women
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University of Texas Southwestern Medical Center
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | August 1, 2018 | ||
| 预计主要完成日期 | August 31, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Muscle sympathetic nerve activity (MSNA)[ Time Frame: Change from baseline resting MSNA to 2 weeks post nitrate supplementation resting MSNA ] Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women | ||
| 正式标题 ICMJE | Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women | ||
| 简要概况 | Women who enter menopause early are at a greater risk for developing cardiovascular disease later in life as compared to women with normal onset of menopause. This increased risk may be due to a prolonged length of time with decreased hormone levels post-menopause; however, this health risk remains understudied. We plan to study why women with early menopause are at higher risk for cardiovascular disease by evaluating their sympathetic nervous system and heart-blood vessel function. In addition, there is lack of promising treatment plans for cardiovascular disease in post-menopausal women. Therefore, we will also test the impact of dietary nitrate on post-menopausal women to determine if it might serve as a potential treatment to reduce risk of cardiovascular disease in older women. |
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| 详细说明 | The current study is recruiting two groups of women aged between 60-70 years old; 1) women who had early natural/non-surgical menopause (age 40-44 yrs) and 2) women who had normal natural/non-surgical menopause (age 50-54). The investigators are recruiting women who do not have any cardiovascular disease, hypertension, diabetes, and other major health issue. The main hypothesis of the project is that early menopause negatively impacts the heart, blood vessel and nerve system due to the increased length of time with reduced hormone levels; which could explain the relationship between early menopause and greater risk of cardiovascular disease in later life. Sympathetic nerve system and cardiovascular functions will be evaluated in both groups to compare the impact of prolonged hormone deficiency. In addition, current study will examine the impact of inorganic nitrate supplementation (beet root juice) to see if there are any favorable changes after 2 weeks of beet root juice intake. There are 2 main test visits in the current study. Visit 1. Nerve system test (maximally take about 5 hours): Participants will rest in the supine position for ≥ 20 mins. Resting heart rate, breathing rate, finger blood pressure will be monitored. Cardiac output will be assessed using the acetylene gas rebreathing technique (1 hour). IV will be inserted for blood draw. Nerve signal search will be performed using a thin needle behind knee to find a signal from a specific nerve. At the same time, transcranial Doppler probe will be placed on the head to look at brain blood flow using soft head gear (1-2 hour). After acceptable signals are obtained, baseline data collection will begin. It will be followed by handgrip exercise and hand immersion to cold water to examine neural sympathetic response to different stimuli (30 mins). After this, to evaluate nerve response to different degrees of passive standings, a bed will be tilted to 30° and 60° for 8 mins each. Blood samples will be obtained in the supine resting position and at the end of 60° tilt (45 mins). Visit 2. Heart and vessel function assessment (Proximately take 2 hours): All measurements are non-invasive for this visit. Participants will rest in the supine position for ≥ 20 mins. Resting heart function will be assessed by ultrasound echocardiography (30mins). Vascular stiffness measurement will be performed using a probe placed on wrist, neck and leg groin area (30 mins). Vascular endothelial function will be measured using flow-mediated dilation and followed by smooth muscle responsiveness test will be performed by measuring brachial artery diameter changes for 10 min following 0.4 mg sublingual nitroglycerin administration (1 hour). After Visit 1-2, participant will be asked to drink either dietary nitrate supplementation or placebo for 2 weeks (randomly assigned). After 2 weeks intervention, participant will come back for post-intervention tests which are identical to visit 1 and 2. After completion of the first intervention, participants will have at least 2 weeks of wash-out period. After 2 weeks participant will be back to the lab and repeat the visit 1 and 2, as well as 2 weeks of dietary nitrate supplementation or placebo. (For those who received 2 weeks of nitrate supplementation for the first intervention, it will be a placebo for this intervention. For those who received placebo for the first intervention, it will be a nitrate supplementation for this intervention). After intervention we will repeat the visit 1 and 2 again. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 2 groups of women (early and normal menopause transition) will be enrolled to crossover design study in a fashion of randomized and double-blinded. 盲法: Interventional 盲法描述:Only research nurse will have an access to the randomization sheet. 主要目的: Prevention |
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| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 31, 2020 | ||
| 预计主要完成日期 | August 31, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Healthy normotensive postmenopausal women - Current age between 60 and 70 years - Who have experienced "natural" or non-surgical menopause Exclusion Criteria: - Any evidence of cardiopulmonary disease - History of hormone replacement therapy in the last 5 years - Chronic kidney disease - Diabetes mellitus - Hypertension - Current abuse of alcohol or drugs and use of tobacco products - Surgical procedure induced menopause | ||
| 性别 |
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| 年龄 | 最小年龄：60 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of Texas Southwestern Medical Center | ||
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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