Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Left ventricular hypertrophy
研究概览
简要总结
Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •type 1 diabetes mellitus
排除标准
- •hypertension
- •coronary artery disease
- •heart valve disease
- •ventricular dysfunction
- •radiotherapy or chemotherapy
- •alcoholism
- •limited acoustic window
结局指标
主要结局
Left ventricular hypertrophy
时间窗: At patient inclusion.
Incidence of patients with LV mass by linear measurements \> 95 g/m2 if women and \> 115 g/m2 if men.
Left ventricular diastolic dysfunction
时间窗: At patient inclusion.
Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when \> 14)
Left atrial dysfunction
时间窗: At patient inclusion.
Incidence of patients with abnormal reservoir strain (normal range: 38%-41%), or abnormal conduit strain (normal range: 21%-25%), or abnormal contractile strain (normal range: 16%-19%).
Preclinical myocardial dysfunction
时间窗: At patient inclusion.
Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
次要结局
未报告次要终点
研究者
Roberto Léo da Silva
Clinical Director
Instituto de Cardiologia de Santa Catarina