Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT00808652|
Recruitment Status : Terminated (not enough recruits)
First Posted : December 16, 2008
Last Update Posted : May 6, 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 or disease||Intervention/treatment|
|Obesity, Morbid Ischemic Heart Disease||Other: Measurement of flow mediated dilation of brachial artery.|
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Other: Measurement of flow mediated dilation of brachial artery.
- 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.
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.
- Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery) [ Time Frame: 1 Year ]
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
|Sheba Medical Center|
|Tel Hashomer, Israel, 52621|