跳至主要内容
临床试验/NCT00808652
NCT00808652终止不适用

Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery)

研究概览

简要总结

The relation between obesity and ischemic heart disease (IHD) is under considerable debate. The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to the state of IHD and its measurement can serve as a surrogate marker for the existence and severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity.

The study includes measurement of endothelial function before and after weight-reducing surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Morbidly obese patients who fulfill the NIH criteria for surgical intervention.

排除标准

  • Patients deemed unfit for surgery
  • Pregnant women, or who are attempting conception.
  • Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography.
  • History of drug or alcohol abuse.
  • Chronic liver disease.

结局指标

主要结局

Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery)

时间窗: 1 Year

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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