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

This study has been terminated.
(not enough recruits)
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: December 12, 2008
Last updated: May 5, 2016
Last verified: May 2016

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.

Condition Intervention
Obesity, Morbid
Ischemic Heart Disease
Other: Measurement of flow mediated dilation of brachial artery.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Measurement of flow mediated dilation of brachial artery.

    Flow-mediated brachial artery reactivity will be measured and flow-mediated vasodilatation will be assessed with the subject's arm using a 15 MHz linear array ultrasound.

    Study Phases:

    1. Flow-mediated (endothelial-dependent) vasodilatation (FMD): Following a 2-minute baseline period, a longitudinal image of the artery will be obtained. A tourniquet placed around the forearm proximal to the target artery will be inflated to a pressure 50 mmHg higher than the subject's systolic blood pressure and held for 5 minutes. Cuff will be then deflated. A continuous scan will be performed at deflation, 60 and 90 seconds after cuff deflation, with frozen and Doppler measurements recorded at similar intervals to the baseline phase.
    2. NTG-induced (non-endothelial-dependent) vasodilatation (NTG): After vessel recovery, sublingual 375 mg of isosorbide dinitrate spray will be administered, and scanning will be performed continuously for 5 minutes thereafter.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbisly obese patients scheduled to undergo bariatric surgery

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00808652

Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center Identifier: NCT00808652     History of Changes
Other Study ID Numbers: SHEBA-5431-08-DG-CTIL 
Study First Received: December 12, 2008
Last Updated: May 5, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Obesity, Morbid
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on October 28, 2016