NCT01536808已完成不适用
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Telomere shortening
研究概览
简要总结
The potential clinical implications of this study are to optimise the selection of a population at risk for developing a diabetic cardiomyopathy among diabetic patients in order to develop early therapeutic strategies to prevent the left ventricular remodelling.
Therefore, the originality of this project is to hypothesize that :
- Diabetes mellitus is often associated with a premature aging syndrome
- Cellular senescence may potentiate the mechanisms that are involved in decreasing myocardial contractility in DM and,
- DM associated to premature aging may increase the risk of developing a cardiomyopathy Thus, the modulation of telomerase activity and the control of telomere length, together with the attenuation of the formation of reactive oxygen species, might represent important new targets in order to develop therapeutic tools in prevention of diabetic cardiomyopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes mellitus
- •40 < Age < 55 years old
- •oral antidiabetic or insulin treatment
- •No symptoms
- •Sinus rhythm
- •no sign or history of heart disease
- •LVEF > 55%
- •Absence of regional left ventricular motion abnormalities.
排除标准
- •absence of sinus rhythm,
- •silent ischemia defined as positive exercise test or positive stress echocardiography,
- •history of cardiomyopathy or CAD,
- •valvular heart disease hemodynamically significant,
- •severe renal insufficiency defined as creatinine clearance < 30 mL/min,
- •echocardiographic images unsuitable for quantification,
- •type 1 diabetes mellitus,
- •Important diabetes mellitus imbalance defined as glycated hemoglobin > 9% or glycemia > 3g/L uncontrolled hypertension (> 180/100 mmHg).
研究组 & 干预措施
Type 2 Diabetes Mellitus
Experimental
干预措施: Cardiac RMI (Other)
Type 2 Diabetes Mellitus
Experimental
干预措施: Analysis telomere (Other)
Type 2 Diabetes Mellitus
Experimental
干预措施: Stress test (Other)
Type 2 Diabetes Mellitus
Experimental
干预措施: echocardiography (Other)
结局指标
主要结局
Telomere shortening
时间窗: 36 months
Investigate whether biomarkers for senescence determined from blood samples, including telomere shortening and telomerase activity in diabetic patients have an impact of left ventricular remodelling as compared with age-matched controls and biological aged control subjects.
次要结局
- Determine the predictive value of alteration(36 months)
- Dysfunction by speckle tracking imaging(36 months)
- Cardiovascular events(36 months)
研究者
研究点 (2)
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