Influence of Osmotic Stimulation of Vasopressin on Autonomic Function
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in autonomic function
研究概览
简要总结
The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females between the ages of 18 - 35
排除标准
- •evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors,
- •previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,
- •regular drug treatment within the previous 15 days,
- •actively attempting to gain or lose body weight,
- •For female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. Females who are currently using contraceptives (e.g., IUD) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.
结局指标
主要结局
Change in autonomic function
时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period
Changes in parasympathetic and sympathetic tone as measured by heart rate variability
次要结局
未报告次要终点
研究者
William Adams
Assistant Professor
University of North Carolina, Greensboro