Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery - Full Text View

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00808652

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Obesity Weight Loss Surgery

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	March 2009
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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.
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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808652

Locations

Israel
Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Contact: David Goitein, MD +97235302714 david.goitein@sheba.health.gov.il
Principal Investigator: David Goitein, MD
Sub-Investigator: Michael Shechter, MD

Sponsors and Collaborators

Sheba Medical Center

More Information

No publications provided

Responsible Party:	Dr. David Goiten, Sheba Medical Cener
ClinicalTrials.gov Identifier:	NCT00808652 History of Changes
Other Study ID Numbers:	SHEBA-5431-08-DG-CTIL
Study First Received:	December 12, 2008
Last Updated:	June 20, 2011
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Obesity
Obesity, Morbid
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis

Arterial Occlusive Diseases
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012