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临床试验/NCT03164148
NCT03164148Unknown不适用

A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test

Seoul St. Mary's Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Changes in Heart rate variability according to the types of pituitary adenoma

研究概览

简要总结

Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. It is also known to predict heart failure, diabetic neuropathy, and even depression.

The combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. Also, the prognosis can be predicted based on this.

In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration) to measure heart rate variability in patients with pituitary adenoma.

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

入排标准

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

入选标准

  • Over 19 year old
  • Those with Normal blood pressure range:
  • 90mmHg <systolic <140mmHg, 60mmHg <diastolic <100mmHg
  • Voluntary participants who visited Seoul St. Mary's Hospital

排除标准

  • Those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts
  • Diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease
  • Pregnant or lactating women
  • Those who drank within 12 hours before participating in the trial
  • Those who are deemed inappropriate by clinical trial researchers

结局指标

主要结局

Changes in Heart rate variability according to the types of pituitary adenoma

时间窗: 5 month of initial recruit

次要结局

未报告次要终点

研究者

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

Dong Jun Lim

Professor

Seoul St. Mary's Hospital

研究点 (2)

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