Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity, Morbid; Ischemic Heart Disease
Intervention: Measurement of flow mediated dilation of brachial artery. (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Sheba Medical Center
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.
Clinical Details
Official title: Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sheba Medical Center, Tel Hashomer 52621, Israel; Recruiting
David Goitein, MD, Phone: +97235302714, Email: david.goitein@sheba.health.gov.il
David Goitein, MD, Principal Investigator
Michael Shechter, MD, Sub-Investigator
Additional Information
Starting date: March 2009
Last updated: June 20, 2011
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