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

Terminated

• Conditions: Ischemic Heart Disease; Obesity, Morbid

• Registration Number: NCT00808652
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Study Start: 2009-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery)	1 Year

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel