Clinical trial NCT03306771: The Relationship Between Morbid Obesity and Carotid Artery Stenosis
Official title: The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Diseases
Morbid Obesity
Metabolic Syndrome
Keywords: Morbid Obesity
Carotid Stenosis
Metabolic Syndrome
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for first bariatric surgery

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.

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.

Eligibility criteria: Inclusion Criteria:

• Candidates for first bariatric surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Correlation between morbid obesity and carotid artery stenosis
timeFrame: 24 months post surgery
Secondary outcomes:
measure: Changes in Intimal -media thickness
timeFrame: Before bariatric surgery, and 6,12,24 months after the surgery
measure: Changes in the carotid artery velocity
timeFrame: Before bariatric surgery, and 6,12,24 months after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: haemek medical center
name: Uri Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1590/s0004-27302006000200009. Epub 2006 May 23. Portuguese.
citation: Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. doi: 10.1053/meta.2001.27213.
citation: 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.
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. doi: 10.1161/01.cir.74.6.1399.
citation: 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.
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.