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临床试验/NCT03260998
NCT03260998Unknown不适用

ECG Changes in Children and Adolescents With Type 1 Diabetes

Assiut University0 个研究点目标入组 120 人开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
corrected QT dispersion

研究概览

简要总结

Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of vascular and neuropathic complications that are seen in patients with diabetes mellitus type 1.

详细描述

Cardiovascular risk factors remain the most controversial chronic complication in diabetes mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the response of the coronary vasculature to sympathetic stimulation, which may manifest clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate variability, which can be assessed qualitatively in the clinic. Limited data suggest silent myocardial ischemia is more common in the presence of cardiac autonomic neuropathy . Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in particular in patients with nephropathy.QT dispersion defined as the difference between maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was defined as the time between the first deflection from the isoelectric PR interval and the visual return of the T wave to the T-P segment ) ,Because these electrocardiogram abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac death , early identification may have prognostic value .

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All children and adolescents with type 1 diabetes

排除标准

  • Cornary artery disease .
  • Heart failure , congenital heart disease ,
  • Rheumatic valve disease .
  • Primary cardiomyopathy .
  • Thyroid dysfunction .
  • Bundle branch block and atrioventricular conduction abnormalities .
  • Anti arrhythmic drugs .

结局指标

主要结局

corrected QT dispersion

时间窗: one day

difference between maximal and minimal corrected QT intervals from different ECG leads

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

Mariam Nagieb

principal investigator

Assiut University

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