NCT01373814已完成不适用
Nutritional Therapy for Diabetic Cardiomyopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- cardiac function
研究概览
简要总结
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be >30 and <65 years of age, in order to limit the confounding affect of age on our endpoints.
- •Subjects must have an ejection fraction >45% (based on their echocardiogram)
- •Patients with T2DM and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis.
排除标准
- •Subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of LV mass and diastolic function.
- •Subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of E'), or current smokers will be excluded.
- •Subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up.
- •We will exclude patients with significant LV systolic dysfunction (ejection fraction <45%)
- •We will not exclude patients with sleep apnea because it does not detrimentally affect LV diastolic function.
- •Subjects will be excluded a priori if they have any history or evidence of liver disease other than NAFLD, consumed >20 g alcohol per day.
结局指标
主要结局
cardiac function
时间窗: 2 weeks
cardiac function as measured by echocardiography incl. tissue Doppler
次要结局
- liver steatosis(2 weeks)
- myocardial steatosis(2 weeks)
- lipidomics(2 weeks)
研究者
研究点 (1)
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