Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.
研究概览
简要总结
Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.
Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure.
To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either normal ejection fraction (EF) or heart failure (EF =<45%)
- •Insulin treated type 2
排除标准
- •Forme stroke with significant physically or mentally disabilitating disorders
- •advanced renal disease (creatinine levels >220 mM)
- •advanced lever disease (alanine aminotransferase > 3 times over reference level).
- •pregnancy
- •other significant disabilitating disorders
研究组 & 干预措施
euglycemia
干预措施: insulin (Drug)
hyperglycemia
干预措施: insulin (Drug)
结局指标
主要结局
1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.
时间窗: 1-4 weeks
Exercise capacity
时间窗: 1-4 months
次要结局
- Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)(1-4 weeks)