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Status unknownNCT03306771Updated Feb 27, 2018

The Relationship Between Morbid Obesity and Carotid Artery Stenosis

An observational study in Carotid Artery Diseases, Morbid Obesity and Metabolic Syndrome, sponsored by HaEmek Medical Center, Israel. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by HaEmek Medical Center, Israel · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carotid Artery Diseases
  • Morbid Obesity
  • Metabolic Syndrome

Keywords

  • Morbid Obesity
  • Carotid Stenosis
  • Metabolic Syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Candidates for first bariatric surgery

Inclusion criteria

  • Candidates for first bariatric surgery

Exclusion criteria

Exclusion Criteria:

  • Smokers or past smokers
  • Patients who are post carotid artery intervention
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic testUltrasound Duplex

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months post surgery

Secondary outcomes

  1. Changes in Intimal -media thickness

    To compare the baseline Intimal-media thickness before surgery to the one post-surgery by the use of Ultrasound

    Time frame: Before bariatric surgery, and 6,12,24 months after the surgery

  2. 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

    Time frame: Before bariatric surgery, and 6,12,24 months after the surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 16767289 ↗
  • Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. doi: 10.1053/meta.2001.27213. Erratum In: Metabolism 2002 Apr;51(4):536. PubMed 11735101 ↗
  • 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. PubMed 12914719 ↗
  • 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. PubMed 3536154 ↗
  • 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. PubMed 27389676 ↗
  • 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. PubMed 19083071 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03306771
Lead sponsor
HaEmek Medical Center, Israel
Responsible party
Uri Kaplan , MD (MD, HaEmek Medical Center, Israel) — Principal investigator
First posted
Oct 11, 2017
Start date
Jun 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Jul 2020 (estimated)
Last update
Feb 27, 2018

Study contacts

Uri Kaplan, MD
Contact
kaplanuri@gmail.com
972-50-5315311
Uri Kaplan, MD
principal investigator · haemek medical center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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