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临床试验/NCT05662930
NCT05662930已完成不适用

Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

Istanbul University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年6月1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
62
试验地点
1
主要终点
Cortisol

研究概览

简要总结

In this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with Hypertension + Diabetes Mellitus (HT+DM) and Hypertension (HT) and to determine the differences between them.

The research was conducted by solving an arithmetic task as a stress test in 62 patients with HT+DM and HT that are being treated in the outpatient clinic of Medical Pharmacology and Clinical Pharmacology Department at Istanbul University, Istanbul Medical Faculty Hospital.

详细描述

In this study, saliva samples were taken for cortisol measurement, and patients were instructed to place the cotton piece in the salivette® tubes directly into their mouths without touching it with anything, hold it for 30-60 seconds, and then insert it back into the tubes in the same way, four times total, once before arithmetic stress and three times after stress, on Tuesdays, Wednesdays, and Thursdays between the hours of 12:00-16:00.

Salivary cortisol was measured using the electro-chemiluminescence immunoassay.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Using antihypertensive treatment for the last 3 months
  • Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months
  • Being between the ages of 40-65
  • Having signed the informed consent form

排除标准

  • Female gender
  • Patients younger than 40 years old or older than 65 years old
  • Uncontrolled blood pressure (SBP>140 mmHg, DBP>90 mmHg)
  • Using antipsychotic medication
  • Using current treatment for less than 3 months
  • Having a previous MI
  • Having a previous stroke
  • Having a lung disease
  • Having organ failure
  • Having Cushing's disease
  • Having aldosteronism
  • Failure to sign the informed consent form

结局指标

主要结局

Cortisol

时间窗: 60 minutes after beginning

A saliva sample is collected

Blood pressure

时间窗: 75 minutes after beginning measurement

The patient is rested by sitting before the measurement

Aldosterone

时间窗: Baseline

Venous blood sample is collected

Heart Rate

时间窗: 75 minutes after beginning

The patient is rested by sitting before the measurement

次要结局

  • Physical activity(Baseline)
  • Mental state examination(Baseline)
  • Health related Quality of life(Baseline)

研究者

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

Iliriana Alloqi Tahirbegolli

Principal investigator

Istanbul University

研究点 (1)

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