<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306771</url>
  </required_header>
  <id_info>
    <org_study_id>0126-17-EMC</org_study_id>
    <nct_id>NCT03306771</nct_id>
  </id_info>
  <brief_title>The Relationship Between Morbid Obesity and Carotid Artery Stenosis</brief_title>
  <official_title>The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The correlation between metabolic syndrome and carotid artery stenosis is well established.&#xD;
      The purpose of this study is to evaluate the relationship between morbid obesity and carotid&#xD;
      artery stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesis is that there is a direct relationship between morbid obesity&#xD;
      and carotid artery stenosis. The investigators hypothesize that metabolic/Bariatric surgery&#xD;
      improves the stenosis in the carotid artery.&#xD;
&#xD;
      This is a prospective comparative study on the candidates for metabolic/Bariatric surgery in&#xD;
      the bariatric center, Emek Medical Center, Afula, Israel. The investigators will compare the&#xD;
      candidate for metabolic surgery with metabolic syndrome risk factors to the ones without&#xD;
      metabolic syndrome risk factors.&#xD;
&#xD;
      The assessment of the carotid artery will be done by Ultrasound Doppler before surgery and 6,&#xD;
      12 and 24 month post surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2018</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between morbid obesity and carotid artery stenosis</measure>
    <time_frame>24 months post surgery</time_frame>
    <description>Evaluate the correlation between the two in order to identify high risk patient for carotid stenosis without metabolic syndrome risk factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Intimal -media thickness</measure>
    <time_frame>Before bariatric surgery, and 6,12,24 months after the surgery</time_frame>
    <description>To compare the baseline Intimal-media thickness before surgery to the one post-surgery by the use of Ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the carotid artery velocity</measure>
    <time_frame>Before bariatric surgery, and 6,12,24 months after the surgery</time_frame>
    <description>To compare the baseline carotid artery velocity before surgery to the one post-surgery by the use of Ultrasound Doppler</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Carotid Artery Diseases</condition>
  <condition>Morbid Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Metabolic syndrome risk factors</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No metabolic Syndrome risk factors</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound Duplex</intervention_name>
    <description>The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery</description>
    <arm_group_label>Metabolic syndrome risk factors</arm_group_label>
    <arm_group_label>No metabolic Syndrome risk factors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Candidates for first bariatric surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Candidates for first bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers or past smokers&#xD;
&#xD;
          -  Patients who are post carotid artery intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uri Kaplan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>haemek medical center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uri Kaplan, MD</last_name>
    <phone>972-50-5315311</phone>
    <email>kaplanuri@gmail.com</email>
  </overall_contact>
  <reference>
    <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>
    <PMID>16767289</PMID>
  </reference>
  <reference>
    <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. Erratum In: Metabolism 2002 Apr;51(4):536.</citation>
    <PMID>11735101</PMID>
  </reference>
  <reference>
    <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>
    <PMID>12914719</PMID>
  </reference>
  <reference>
    <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>
    <PMID>3536154</PMID>
  </reference>
  <reference>
    <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>
    <PMID>27389676</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19083071</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>February 25, 2018</last_update_submitted>
  <last_update_submitted_qc>February 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Uri Kaplan , MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Morbid Obesity</keyword>
  <keyword>Carotid Stenosis</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306771
org study id: 0126-17-EMC
nct id: NCT03306771
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Correlation between morbid obesity and carotid artery stenosis
time frame: 24 months post surgery
description: Evaluate the correlation between the two in order to identify high risk patient for carotid stenosis without metabolic syndrome risk factors
measure: Changes in Intimal -media thickness
time frame: Before bariatric surgery, and 6,12,24 months after the surgery
description: To compare the baseline Intimal-media thickness before surgery to the one post-surgery by the use of Ultrasound
measure: Changes in the carotid artery velocity
time frame: Before bariatric surgery, and 6,12,24 months after the surgery
description: To compare the baseline carotid artery velocity before surgery to the one post-surgery by the use of Ultrasound Doppler
arm group label: Metabolic syndrome risk factors
description: 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
arm group label: No metabolic Syndrome risk factors
description: 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
intervention type: Diagnostic Test
intervention name: Ultrasound Duplex
description: The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery
arm group label: Metabolic syndrome risk factors
arm group label: No metabolic Syndrome risk factors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Uri Kaplan, MD
role: Principal Investigator
affiliation: haemek medical center
last name: Uri Kaplan, MD
phone: 972-50-5315311
email: kaplanuri@gmail.com
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.
PMID: 16767289
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. Erratum In: Metabolism 2002 Apr;51(4):536.
PMID: 11735101
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.
PMID: 12914719
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.
PMID: 3536154
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.
PMID: 27389676
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.
PMID: 19083071
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Uri Kaplan , MD
investigator title: MD
mesh term: Carotid Stenosis
mesh term: Carotid Artery Diseases
mesh term: Obesity
mesh term: Metabolic Syndrome
mesh term: Obesity, Morbid
mesh term: Constriction, Pathologic
sharing ipd: No