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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808652
First Posted: December 16, 2008
Last Update Posted: May 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose

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 ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbisly obese patients scheduled to undergo bariatric surgery
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808652


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

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00808652     History of Changes
Other Study ID Numbers: SHEBA-5431-08-DG-CTIL
First Submitted: December 12, 2008
First Posted: December 16, 2008
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Obesity, Morbid
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms