The Relationship Between Morbid Obesity and Carotid Artery Stenosis

NCT ID: NCT03306771

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Carotid Artery Diseases Morbid Obesity Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Ultrasound Duplex

Intervention Type DIAGNOSTIC_TEST

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

Ultrasound Duplex

Intervention Type DIAGNOSTIC_TEST

The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery

Interventions

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Ultrasound Duplex

The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

• Candidates for first bariatric surgery

Exclusion Criteria

* Smokers or past smokers
* Patients who are post carotid artery intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Uri Kaplan , MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uri Kaplan, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Central Contacts

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Uri Kaplan, MD

Role: CONTACT

972-50-5315311

References

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Ribeiro Filho FF, Mariosa LS, Ferreira SR, Zanella MT. [Visceral fat and metabolic syndrome: more than a simple association]. Arq Bras Endocrinol Metabol. 2006 Apr;50(2):230-8. doi: 10.1590/s0004-27302006000200009. Epub 2006 May 23. Portuguese.

Reference Type BACKGROUND
PMID: 16767289 (View on PubMed)

Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. doi: 10.1053/meta.2001.27213.

Reference Type BACKGROUND
PMID: 11735101 (View on PubMed)

Sharma AM. Obesity and cardiovascular risk. Growth Horm IGF Res. 2003 Aug;13 Suppl A:S10-7. doi: 10.1016/s1096-6374(03)00047-9.

Reference Type BACKGROUND
PMID: 12914719 (View on PubMed)

Pignoli P, Tremoli E, Poli A, Oreste P, Paoletti R. Intimal plus medial thickness of the arterial wall: a direct measurement with ultrasound imaging. Circulation. 1986 Dec;74(6):1399-406. doi: 10.1161/01.cir.74.6.1399.

Reference Type BACKGROUND
PMID: 3536154 (View on PubMed)

Marchesi F, Giacosa R, Reggiani V, De Sario G, Tartamella F, Melani E, Mita MT, Cinieri FG, Cecchini S, Ricco' M, Salcuni P, Roncoroni L. Morphological Changes in the Carotid Artery Intima after Gastric Bypass for Morbid Obesity. Obes Surg. 2017 Feb;27(2):357-363. doi: 10.1007/s11695-016-2279-9.

Reference Type BACKGROUND
PMID: 27389676 (View on PubMed)

Sarmento PL, Plavnik FL, Zanella MT, Pinto PE, Miranda RB, Ajzen SA. Association of carotid intima-media thickness and cardiovascular risk factors in women pre- and post-bariatric surgery. Obes Surg. 2009 Mar;19(3):339-44. doi: 10.1007/s11695-008-9783-5. Epub 2008 Dec 13.

Reference Type BACKGROUND
PMID: 19083071 (View on PubMed)

Other Identifiers

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0126-17-EMC

Identifier Type: -

Identifier Source: org_study_id

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