Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Left ventricular function
研究概览
简要总结
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.
The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection fraction =<45%
- •Hba1c =>7,5%
- •In anticongestive treatment
- •NYHA class 2-4
排除标准
- •Severe angina (CCS 3-4)
- •Hemodynamic significant heart valve disease
- •Congenital heart disease
- •Pregnancy
研究组 & 干预措施
optimized diabetic control
each participant will be assigned to be optimized in a dedicated diabetic clinic
干预措施: all antidiabetic drugs will be appliable (Other)
control
participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period.
结局指标
主要结局
Left ventricular function
时间窗: 4 month
Left ventricular function will be evaluated using echocardiografi measuring: - 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.
次要结局
- Exercise capacity and peak oxygen consumption(4 month)
- 6-minutes hall walk test(4 month)
- hormonal and metabolic profile(4 month)
- Muscle strength and mass(4 month)