The Relationship Between Morbid Obesity and Carotid Artery Stenosis

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03306771
• Other study ID #: 0126-17-EMC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 1, 2017
• Last updated: February 25, 2018
• Start date: June 2018
• Est. completion date: July 2020

Study information

• Verified date: October 2017
• Source: HaEmek Medical Center, Israel
• Contact: Uri Kaplan, MD
• Phone: 972-50-5315311
• Email: kaplanuri[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidates for first bariatric surgery

Exclusion Criteria:

• Smokers or past smokers

• Patients who are post carotid artery intervention

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Stenosis
• Constriction, Pathologic
• Metabolic Syndrome
• Metabolic Syndrome X
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

References & Publications (6)

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. — View Citation

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. — View Citation

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. Epub 2006 May 23. Review. Portuguese. — View Citation

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. — View Citation

Sharma AM. Obesity and cardiovascular risk. Growth Horm IGF Res. 2003 Aug;13 Suppl A:S10-7. Review. — View Citation

Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. Review. Erratum in: Metabolism 2002 Apr;51(4):536. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between morbid obesity and carotid artery stenosis	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	Changes in Intimal -media thickness	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
Secondary	Changes in the carotid artery velocity	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