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The Relationship Between Morbid Obesity and Carotid Artery Stenosis

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ClinicalTrials.gov Identifier: NCT03306771
Recruitment Status : Not yet recruiting
First Posted : October 11, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Uri Kaplan , MD, 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.

Condition or disease Intervention/treatment
Carotid Artery Diseases Morbid Obesity Metabolic Syndrome Diagnostic Test: Ultrasound Duplex

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Candidates for first bariatric surgery
Criteria

Inclusion Criteria:

• Candidates for first bariatric surgery

Exclusion Criteria:

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

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): NCT03306771


Contacts
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Contact: Uri Kaplan, MD 972-50-5315311 kaplanuri@gmail.com

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Uri Kaplan, MD haemek medical center

Publications:
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Responsible Party: Uri Kaplan , MD, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03306771     History of Changes
Other Study ID Numbers: 0126-17-EMC
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Uri Kaplan , MD, HaEmek Medical Center, Israel:
Morbid Obesity
Carotid Stenosis
Metabolic Syndrome

Additional relevant MeSH terms:
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Metabolic Syndrome
Obesity
Constriction, Pathologic
Obesity, Morbid
Carotid Artery Diseases
Carotid Stenosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathological Conditions, Anatomical
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases