The Relationship Between Morbid Obesity and Carotid Artery Stenosis

February 25, 2018 updated by: Uri Kaplan , MD, HaEmek Medical Center, Israel

The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Candidates for first bariatric surgery

Description

Inclusion Criteria:

• Candidates for first bariatric surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metabolic syndrome risk factors
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
Diagnostic test: Ultrasound Duplex
The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery
No metabolic Syndrome risk factors
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
Diagnostic test: Ultrasound Duplex
The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between morbid obesity and carotid artery stenosis
Time Frame: 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
24 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Intimal -media thickness
Time Frame: 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
Before bariatric surgery, and 6,12,24 months after the surgery
Changes in the carotid artery velocity
Time Frame: 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
Before bariatric surgery, and 6,12,24 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Uri Kaplan, MD, Haemek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

October 1, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 25, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0126-17-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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