跳至主要内容
临床试验/NCT03636490
NCT03636490已完成不适用

Psychological Stress, and Circadian Patterns of Sodium Excretion and Blood Pressure

Columbia University1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2018年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
323
试验地点
1
主要终点
Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)

研究概览

简要总结

The study will examine urinary sodium excretion induced by psychological stress and its diurnal pattern as a novel biological mechanism that may underlie an abnormal diurnal pattern of blood pressure. The study will test the hypotheses that lower stress-induced sodium excretion is associated with an abnormal diurnal pattern of sodium excretion, and that an abnormal diurnal pattern of sodium excretion is associated with an abnormal diurnal pattern of blood pressure.

Primary Aim 1: To examine the association between urinary sodium excretion after provoked psychological stress and the diurnal pattern of sodium excretion.

Primary Aim 2: To examine the association between the diurnal pattern of sodium excretion and the diurnal pattern of BP.

Secondary Aim: To examine whether the association between urinary sodium excretion after provoked stress and the diurnal pattern of sodium excretion is modified by ecological momentary levels of perceived stress, experienced during the daytime period.

Exploratory Aim: To determine the socio-demographic, behavioral, and psychological traits, chronic stress, and biological stress-related factors that are associated with lower stress-induced sodium excretion. Identification of these factors will help determine who is at risk for having a differential sodium excretion response to psychological stress.

详细描述

Blood pressure (BP) has a diurnal rhythm; it is normally highest during the daytime period and lowest during the nighttime period (BP dipping). The diurnal pattern of BP over a 24-hour period can be assessed using ambulatory BP monitoring (ABPM). Evidence indicates that an abnormal diurnal pattern of BP on ABPM, defined by reduced BP dipping or elevated nighttime BP, is associated with an increased risk of cardiovascular disease (CVD) events.

Psychological stress occurs when an individual perceives that the environmental demands exceed his/her adaptive capacity. An individual's response to events that are representative of this overload, such as perceived stress and negative affect including anger, hostility, depression, vital exhaustion, and symptoms of posttraumatic stress disorder, are associated with reduced BP dipping and/or higher nighttime BP. Exposure to environmental factors which tax an individual's ability to cope, including lower socioeconomic status, job strain, and perceived racism, are also associated with reduced BP dipping and/or higher nighttime BP. This study will examine the disruption of the normal diurnal pattern of sodium excretion by psychological stress as a novel biological mechanism underlying an abnormal diurnal pattern of BP.

The study will be conducted both in the laboratory and in the naturalistic environment with a multi-ethnic sample of 211 adult community participants from upper Manhattan who do not have a history of CVD, diabetes, chronic kidney disease, or another major medical condition and are not taking antihypertensive medication. During a laboratory visit, urinary sodium excretion in response to mental stress tasks will be examined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

All participants will receive the same intervention. All associated groups will be aware of the intervention protocol and the single-arm study model.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 years or older
  • Screening mean blood pressure less than or equal to 160/105 mm Hg

排除标准

  • History of overt cardiovascular disease (coronary heart disease, stroke, peripheral arterial disease, heart failure, permanent or recurring arrhythmia)
  • History of secondary hypertension
  • History of other major medical condition (cancer, rheumatologic diseases, immunologic diseases, etc.)
  • Taking anti-hypertensive medications or other medications that are known to substantially affect blood pressure (e.g. steroids, chronic anti-inflammatory medications, etc.)
  • Non-English speaking

结局指标

主要结局

Ratio of Awake-to-asleep Urinary Sodium Excretion Rate (Aim 1)

时间窗: Over 24-hour ambulatory period

Systolic Blood Pressure Dipping (Aim 2)

时间窗: Over 24-hour ambulatory period

Systolic blood pressure (SBP) dipping refers to the normal physiological decline in SBP during nighttime sleep. SBP dipping (%) was calculated as 100 \* (mean awake SBP - mean asleep SBP) / (mean awake SBP).

次要结局

  • 24-hour Potassium Excretion(Over 24-hour ambulatory period)
  • 24-hour Creatinine Clearance(Over 24-hour ambulatory period)
  • Mean Perceived Stress Level(Over 24-hour ambulatory period)
  • 24-hour Sodium Excretion(Over 24-hour ambulatory period)
  • Fractional Excretion of Sodium(Over 24-hour ambulatory period)
  • EMA Stress(Over 24-hour ambulatory period)
  • EMA Anger(Over 24-hour ambulatory period)
  • EMA Aggravation(Over 24-hour ambulatory period)
  • EMA Anxiety(Over 24-hour ambulatory period)
  • EMA Depressed(Over 24-hour ambulatory period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daichi Shimbo

Professor of Medicine, Dept of Med

Columbia University

研究点 (1)

Loading locations...

相似试验