The Relationship Between Morbid Obesity and Carotid Artery Stenosis

• Conditions: Carotid Artery Diseases; Morbid Obesity; Metabolic Syndrome
• Interventions: Diagnostic Test: Ultrasound Duplex

• Registration Number: NCT03306771
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.

Detailed Description

The investigators hypothesis is that there is a direct relationship between morbid obesity and carotid artery stenosis. The investigators hypothesize that metabolic/Bariatric surgery improves the stenosis in the carotid artery.

This is a prospective comparative study on the candidates for metabolic/Bariatric surgery in the bariatric center, Emek Medical Center, Afula, Israel. The investigators will compare the candidate for metabolic surgery with metabolic syndrome risk factors to the ones without metabolic syndrome risk factors.

The assessment of the carotid artery will be done by Ultrasound Doppler before surgery and 6, 12 and 24 month post surgery.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-11
• Last Update Submitted: 2018-02-25
• Last Update Posted: 2018-02-27
• Study Start: 2018-06
• Primary Completion: 2019-04
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Candidates for first bariatric surgery

Exclusion Criteria

• Smokers or past smokers
• Patients who are post carotid artery intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metabolic syndrome risk factors	Ultrasound Duplex	Candidates for bariatric surgery who have metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity
No metabolic Syndrome risk factors	Ultrasound Duplex	Candidates for bariatric surgery who lack metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity

Primary Outcome Measures

Name	Time	Method
Correlation between morbid obesity and carotid artery stenosis	24 months post surgery	Evaluate the correlation between the two in order to identify high risk patient for carotid stenosis without metabolic syndrome risk factors

Secondary Outcome Measures

Name	Time	Method
Changes in Intimal -media thickness	Before bariatric surgery, and 6,12,24 months after the surgery	To compare the baseline Intimal-media thickness before surgery to the one post-surgery by the use of Ultrasound
Changes in the carotid artery velocity	Before bariatric surgery, and 6,12,24 months after the surgery	To compare the baseline carotid artery velocity before surgery to the one post-surgery by the use of Ultrasound Doppler