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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03306771
Other study ID # 0126-17-EMC
Secondary ID
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
Health authority
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

Study Design


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
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