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临床试验/NCT04208295
NCT04208295Unknown不适用

24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics

University of Aarhus1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
24 hour Blood Pressure

研究概览

简要总结

Autonomic neuropathy is a common complication of type 2 diabetes mellitus. Symptoms from cardiovascular autonomic neuropathy include, dizziness, orthostatic hypotension and insufficient heart rate and blood pressure (BP) regulation during physical exertion. The degree of cardiovascular autonomic neuropathy is most commonly measured as cardiac autonomic neuropathy based on at least two abnormal cardiac reflex tests, which primarily measures parasympathetic indices of the autonomic nervous system (ANS).

Few measures are available for quantifying the sympathetic/adrenergic branch of the ANS.

Circadian changes in BP is a documented measure of BP variability, regulated centrally by a multitude of centers. A growing number of studies indicate that a diminished BP variability is associated with increased cardiovascular risk and injury. The ANS plays a pivotal role in the execution of these circadian BP changes, mainly through sympathetic adrenergic nerve fibers

Few studies have investigated the applicability of 24-hour indices as predictor for autonomic adrenergic dysfunction. No previous studies have investigated the association between clinical markers of adrenergic function, and 24-hour blood pressure indices in type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Type 2 diabetes
  • Normal 12-lead ECG

排除标准

  • Significant cardiovascular, muscular, lung, kidney or psychiatric disease
  • Pregnancy
  • Malignant disease, HIV, alcoholism or drug abuse
  • Parkinson disease
  • Ischemic heart disease
  • Vital medicine that can affect the autonomic nervous system

结局指标

主要结局

24 hour Blood Pressure

时间窗: 0

Day/night blood pressure ratio. Day time standard deviation and average real time variation

Autonomic adrenergic measure

时间窗: 0

Valsalva maneuver - Phase 2Late, Pressure recovery time, Baroreceptor sensitivity, Phase 4 rise. Head up tilt test - Blood pressure dip ratio

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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