Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, 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
- 2
- 主要终点
- Left ventricular function
研究概览
简要总结
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.
Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ejection fraction at or lower than 45%
- •type 2 diabetes
排除标准
- •known s-creatinine >220mM
- •known S-alanine aminotransferase >3 times normal upper limit
- •other disabilitating conditions
- •pregnancy
- •insulin treatment
结局指标
主要结局
Left ventricular function
时间窗: 1-6 weeks
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate). Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
intracellular lipid content
时间窗: 1-6 weeks
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content). Outcome is difference between low and high ciculating free fatty acids.
Exercise capacity and oxygen consumption
时间窗: 1-6 weeks
Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.
次要结局
- Regional left ventricular function(1-6 weeks)
- 6 minutes hall walk test(1-6 weeks)
- metabolic and hormonal profile(1-6 weeks)