<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/NCT03273621</url>
  </required_header>
  <id_info>
    <org_study_id>EAT-BS _01</org_study_id>
    <nct_id>NCT03273621</nct_id>
  </id_info>
  <brief_title>Bariatric Surgery and Epicardial Adipose Tissue: a MRI Study</brief_title>
  <official_title>Effetti di Differenti Tipologie di Intervento di Chirurgia Bariatrica Sul Tessuto Adiposo Epicardico e su Alcuni Parametri Morfologici e Funzionali Cardiovascolari, Valutati Con Risonanza Magnetica Nucleare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to measure the volume of the epicardial adispose tissue (EAT) and&#xD;
      other morphological and functional cardiovascular parameters in subjects with severe obesity,&#xD;
      using an open magnetic resonance unit capable of holding up to 220 kg of weight. These&#xD;
      measurements will be repeated a year after bariatric surgery to assess the effect of the&#xD;
      weight loss on EAT. The possible difference among different types of bariatric surgery will&#xD;
      be considered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational study, 28 obese male and female subjects underwent&#xD;
      bariatric surgery will be studied: 14 subjects candidates for SG and 14 at RYGB. These&#xD;
      patients will enrolled in this type of intervention at the INCO bariatric surgery unit&#xD;
      (National Institute for Obesity). All patients are first evaluated by a multidisciplinary&#xD;
      team to establish adherence to the criteria suggested by the guidelines for bariatric&#xD;
      surgery.&#xD;
&#xD;
      All enrolled subjects will be subjected to the following protocol within one month prior to&#xD;
      surgery and one year (±1 month) after surgery:&#xD;
&#xD;
        1. CMR without contrast medium with 1-T (Panorama, Philips) open device for the measurement&#xD;
           of EAT volume in systoles and diastoles for the evaluation of the main morpho-functional&#xD;
           parameters (left ventricular size and mass , Right ventricular size, atrial size, left&#xD;
           and right ventricular systolic function, diastolic left and right ventricular function)&#xD;
           and for evaluating the elasticity of the thoracic aortic wall, evaluated as compliance&#xD;
           and stiffness (duration of examination About 30 minutes).&#xD;
&#xD;
        2. performing axial MRI scans without contrast medium at the IV lumbar vertebra for&#xD;
           quantification of abdominal and subcutaneous adipose tissue;&#xD;
&#xD;
        3. direct detection of anthropometric indexes (weight, height, abdominal circumference, hip&#xD;
           circumference);&#xD;
&#xD;
        4. measurement of systolic and diastolic blood pressure with sphygmomanometer;&#xD;
&#xD;
        5. assessment of body composition by bioimpedenzometry with estimate of fat and lean mass&#xD;
           expressed in kg and in percentage.&#xD;
&#xD;
      The examinations will be carried out following the normal procedures provided by clinical&#xD;
      practice and all scans performed by Magnetic Resonance will be performed at the Italian&#xD;
      Diagnostic Center (CDI), Via Saint Bon, 20 - 20147 Milan (which has MRI equipment open).&#xD;
      Other investigations will be carried out at the Istituto Nazionale per la cura del dono&#xD;
      (INCO) of the Sant'Ambrogio Clinical Institute.&#xD;
&#xD;
      The sample size was calculated assuming that an average thickness of 12.3±1.8 mm (Iacobellis&#xD;
      G. at al, 2008) is expected to reduce the thickness by approximately 30% to 4 ± 0.8 mm (from&#xD;
      An average epicardial fat content of 137 ± 37 ml is expected to be about 30% reduction of 39&#xD;
      ± 12 ml). With a 90% power and alpha error of 5% (two-tailed) we have obtained a minimum&#xD;
      number of 22 subjects. Assuming a 20% loss to follow-up, approximately 28 subjects should be&#xD;
      recruited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EAT volume</measure>
    <time_frame>Immediately after MRI</time_frame>
    <description>The EAT volume will be measured in ml by manul segmentation of magnetic resonance images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EAT thickness</measure>
    <time_frame>Immediately after MRI</time_frame>
    <description>The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>Patients with a body mass index larger than 35 kg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatic surgery</intervention_name>
    <description>One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.</description>
    <arm_group_label>Obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients with bariatric surgery&#xD;
&#xD;
          2. informed written consent&#xD;
&#xD;
          3. between the ages of 18 and 65&#xD;
&#xD;
          4. patients with body mass index (BMI) ≥ 40 kg / m2&#xD;
&#xD;
          5. patients with 35 ≤ BMI &lt;40 kg / m2 in the presence of comorbidities that could improve&#xD;
             or cure following the remarkable and persistent weight loss achieved with the&#xD;
             intervention (metabolic diseases, cardiorespiratory diseases, severe joint disorders,&#xD;
             severe psychological problems, etc.)&#xD;
&#xD;
          6. patients with 35 ≤ BMI &lt;40 kg / m2 with previous failure of proper medical treatment&#xD;
             (lack or insufficient weight loss, lack or lack of long-term maintenance of weight&#xD;
             loss).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. lack of informed written consent&#xD;
&#xD;
          2. presence of known ischemic or valvular heart disease&#xD;
&#xD;
          3. pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinica San'Ambrogio</name>
      <address>
        <city>Milan</city>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Francesco Sardanelli</investigator_full_name>
    <investigator_title>Head of Radiology Department</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03273621
org study id: EAT-BS _01
nct id: NCT03273621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to measure the volume of the epicardial adispose tissue (EAT) and
      other morphological and functional cardiovascular parameters in subjects with severe obesity,
      using an open magnetic resonance unit capable of holding up to 220 kg of weight. These
      measurements will be repeated a year after bariatric surgery to assess the effect of the
      weight loss on EAT. The possible difference among different types of bariatric surgery will
      be considered.
In this prospective observational study, 28 obese male and female subjects underwent
      bariatric surgery will be studied: 14 subjects candidates for SG and 14 at RYGB. These
      patients will enrolled in this type of intervention at the INCO bariatric surgery unit
      (National Institute for Obesity). All patients are first evaluated by a multidisciplinary
      team to establish adherence to the criteria suggested by the guidelines for bariatric
      surgery.

      All enrolled subjects will be subjected to the following protocol within one month prior to
      surgery and one year (±1 month) after surgery:

        1. CMR without contrast medium with 1-T (Panorama, Philips) open device for the measurement
           of EAT volume in systoles and diastoles for the evaluation of the main morpho-functional
           parameters (left ventricular size and mass , Right ventricular size, atrial size, left
           and right ventricular systolic function, diastolic left and right ventricular function)
           and for evaluating the elasticity of the thoracic aortic wall, evaluated as compliance
           and stiffness (duration of examination About 30 minutes).

        2. performing axial MRI scans without contrast medium at the IV lumbar vertebra for
           quantification of abdominal and subcutaneous adipose tissue;

        3. direct detection of anthropometric indexes (weight, height, abdominal circumference, hip
           circumference);

        4. measurement of systolic and diastolic blood pressure with sphygmomanometer;

        5. assessment of body composition by bioimpedenzometry with estimate of fat and lean mass
           expressed in kg and in percentage.

      The examinations will be carried out following the normal procedures provided by clinical
      practice and all scans performed by Magnetic Resonance will be performed at the Italian
      Diagnostic Center (CDI), Via Saint Bon, 20 - 20147 Milan (which has MRI equipment open).
      Other investigations will be carried out at the Istituto Nazionale per la cura del dono
      (INCO) of the Sant'Ambrogio Clinical Institute.

      The sample size was calculated assuming that an average thickness of 12.3±1.8 mm (Iacobellis
      G. at al, 2008) is expected to reduce the thickness by approximately 30% to 4 ± 0.8 mm (from
      An average epicardial fat content of 137 ± 37 ml is expected to be about 30% reduction of 39
      ± 12 ml). With a 90% power and alpha error of 5% (two-tailed) we have obtained a minimum
      number of 22 subjects. Assuming a 20% loss to follow-up, approximately 28 subjects should be
      recruited.
observational model: Case-Only
time perspective: Prospective
measure: EAT volume
time frame: Immediately after MRI
description: The EAT volume will be measured in ml by manul segmentation of magnetic resonance images
measure: EAT thickness
time frame: Immediately after MRI
description: The EAT maximal thickness will be measured in mm by using an electronic caliper on magnetic resonance images
arm group label: Obese
description: Patients with a body mass index larger than 35 kg/m2
intervention type: Procedure
intervention name: Bariatic surgery
description: One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.
arm group label: Obese
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Francesco Sardanelli
investigator title: Head of Radiology Department
sharing ipd: Undecided