Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)
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"
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Region Midjylland
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Aarhus、Region Midjylland、丹麦、8200
- Dept. of cardiology, Aarhus University hospital Skejby,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ejection fraction at or lower than 45%
- type 2 diabetes
Exclusion Criteria:
- known s-creatinine >220mM
- known S-alanine aminotransferase >3 times normal upper limit
- other disabilitating conditions
- pregnancy
- insulin treatment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：High circulating free fatty acids
using Heparin af intralipid infusion for 8 hours
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for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
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有源比较器：Low circulation free fatty acids
using hyperinsulinaemic euglycemic clamp for 8 hours
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low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Left ventricular function
大体时间：1-6 weeks
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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. |
1-6 weeks
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intracellular lipid content
大体时间：1-6 weeks
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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. |
1-6 weeks
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Exercise capacity and oxygen consumption
大体时间：1-6 weeks
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Using treadmill and continues oxygen consumption measurement.
Outcome is difference between low and high ciculating free fatty acids.
|
1-6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Regional left ventricular function
大体时间：1-6 weeks
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regional speckle tracking during rest and peak exercise.
Outcome is difference between low and high ciculating free fatty acids.
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1-6 weeks
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6 minutes hall walk test
大体时间：1-6 weeks
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distance difference between low and high levels of circulating FFA.
Outcome is difference between low and high ciculating free fatty acids.
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1-6 weeks
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metabolic and hormonal profile
大体时间：1-6 weeks
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bloodsamples
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1-6 weeks
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合作者和调查者
调查人员
- 首席研究员：Roni R Nielsen, MD、Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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