<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/NCT01700738</url>
  </required_header>
  <id_info>
    <org_study_id>2012 - A00555-38</org_study_id>
    <nct_id>NCT01700738</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effects of Laying Early a Gastric Band on the Prevention of Morbid Obesity Randomized Checked Against Standard Management of Obesity in This Population.</brief_title>
  <acronym>CHADO</acronym>
  <official_title>Evaluation of the Effects of Laying Early (Between 12 and 16) a Gastric Band on the Prevention of Morbid Obesity in Late Adolescence. Randomized Checked Against Standard Management of Obesity in This Population.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with&#xD;
      &quot;conventional&quot; treatment of obesity.&#xD;
&#xD;
      SECONDARY OBJECTIVES&#xD;
&#xD;
        -  Compare the effects of the placement of a gastric band with &quot;conventional&quot; treatment of&#xD;
           obesity on quality of life, body composition and parameters of the metabolic syndrome.&#xD;
&#xD;
        -  Identify predictors of &quot;good answer to the ring&quot; to determine the best future&#xD;
           indications.&#xD;
&#xD;
        -  Study of the gastric tolerance.&#xD;
&#xD;
      INCLUSION CRITERIA&#xD;
&#xD;
        1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is&#xD;
           greater than IMCZ-score &gt; 4 DP&gt; 8 kg&#xD;
&#xD;
        2. Obesity &quot;common&quot; non-syndromic.&#xD;
&#xD;
        3. Medical decision of surgical placement of laparoscopic gastric banding.&#xD;
&#xD;
        4. Adolescent and family who understand and accept the need for medical and surgical follow&#xD;
           long term.&#xD;
&#xD;
        5. Adolescent and family who fully understood the oral and written information explaining&#xD;
           the study and the need for prolonged follow-up.&#xD;
&#xD;
        6. Obtention of oral and written consent of the adolescent and the parents.&#xD;
&#xD;
        7. Parents and adolescents affiliated with the social security system.&#xD;
&#xD;
      NONINCLUSION CRITERIA&#xD;
&#xD;
        1. Intellectual Deficit.&#xD;
&#xD;
        2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.&#xD;
&#xD;
        3. Obesity with severe binge eating.&#xD;
&#xD;
        4. Pregnancy or wishes of pregnancy in the following year.&#xD;
&#xD;
        5. Non accession adolescent and / or family in the process of medical care before&#xD;
           inclusion.&#xD;
&#xD;
        6. Predictable post surgical monitoring difficulties.&#xD;
&#xD;
        7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.&#xD;
&#xD;
        8. Participation in a clinical study evaluating a treatment during the 2 years of the&#xD;
           study.&#xD;
&#xD;
      EXCLUSION CRITERIA&#xD;
&#xD;
        1. Anesthetic contre indication for placement of a gastric laparoscopic.&#xD;
&#xD;
        2. IMC&gt; 50 kg/m2 the day of inclusion.&#xD;
&#xD;
      STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient&#xD;
      and his family. Patients will then be enrolled and randomized. Patients in group A (surgery&#xD;
      group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in&#xD;
      group B start conventional monitoring dietary medical and physical. For both groups follow-up&#xD;
      visits will occur every 3 months for 2 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMIZ-score evolution in 2 years.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of quality of life scales</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of des alimentary attitudinal troubles and psychiatrical troubles</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of BMIZ-score</measure>
    <time_frame>1, 5 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of round-waist</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of bodily composition.</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of metabolic syndrome parameters.</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of respiratory parameters: polysomnography</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of success factors of the ring.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study of tolerance of the gastric ring.</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>gastric ring surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in this group a gastric ring will be put by surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nutritional help</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the usual treatment of obesity in France with nutritional care will be dispensed for this arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastric ring surgery</intervention_name>
    <arm_group_label>gastric ring surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nutritional help</intervention_name>
    <arm_group_label>nutritional help</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is&#xD;
             greater than IMCZ-score &gt; 4 DP&gt; 8 kg&#xD;
&#xD;
          2. Obesity &quot;common&quot; non-syndromic.&#xD;
&#xD;
          3. Medical decision of surgical placement of laparoscopic gastric banding.&#xD;
&#xD;
          4. Adolescent and family who understand and accept the need for medical and surgical&#xD;
             follow long term.&#xD;
&#xD;
          5. Adolescent and family who fully understood the oral and written information explaining&#xD;
             the study and the need for prolonged follow-up.&#xD;
&#xD;
          6. Obtention of oral and written consent of the adolescent and the parents.&#xD;
&#xD;
          7. Parents and adolescents affiliated with the social security system.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          1. Intellectual Deficit.&#xD;
&#xD;
          2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.&#xD;
&#xD;
          3. Obesity with severe binge eating.&#xD;
&#xD;
          4. Pregnancy or wishes of pregnancy in the following year.&#xD;
&#xD;
          5. Non accession adolescent and / or family in the process of medical care before&#xD;
             inclusion.&#xD;
&#xD;
          6. Predictable post surgical monitoring difficulties.&#xD;
&#xD;
          7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.&#xD;
&#xD;
          8. Participation in a clinical study evaluating a treatment during the 2 years of the&#xD;
             study.&#xD;
&#xD;
          9. Anesthetic contre indication for placement of a gastric laparoscopic.&#xD;
&#xD;
         10. IMC&gt; 50 kg/m2 the day of inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>REGIS COUTANT</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSITY HOSPITAL OF ANGERS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>REGIS COUTANT</last_name>
    <email>recoutant@chu-angers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>REGIS COUTANT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>FRANCOISE SCHMITT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>GUILLAUME PODEVIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>JEAN-LOUIS GINIES</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>AGNES SALLE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>DOMINIQUE BOUGLE</last_name>
      <phone>0231515161</phone>
    </contact>
    <investigator>
      <last_name>DOMINIQUE BOUGLE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>JULIEN ROD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>MURIEL LAURANS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>YANNICK LE ROUX</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>MARIE-ASTRID PIQUET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital Bicêtre</name>
      <address>
        <city>Le Kremlin Bicetre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>PIERRE BOUGNIERES</last_name>
      <phone>0145217832</phone>
    </contact>
    <investigator>
      <last_name>PIERRE BOUGNIERE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>GIANPAOLO DE FILIPPO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>CATHERINE PIQUARD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>IVA GUEORGUIEVA</last_name>
      <phone>0320446885</phone>
    </contact>
    <investigator>
      <last_name>IVA GUEORGUIEVA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>JACQUES WEILL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>ESTELLE AUBRY</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>FRANCOIS PATTOU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>MARIE PIGEYRE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Necker</name>
      <address>
        <city>Paris</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>OLIVIER GOULET</last_name>
      <phone>0144492501</phone>
    </contact>
    <investigator>
      <last_name>OLIVIER GOULET</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>MYRIAM TYAN-DABBAS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>NAZIHA KHEN-DUNLOP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>MAITHE TAUBER</last_name>
      <phone>0534558555</phone>
    </contact>
    <investigator>
      <last_name>MAITHE TAUBER</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>GWENAELLE DIENE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>BEATRICE JOURET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>PATRICK RITZ</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <!-- 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/NCT01700738
org study id: 2012 - A00555-38
nct id: NCT01700738
lead sponsor: 
has dmc: No
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with
      "conventional" treatment of obesity.

      SECONDARY OBJECTIVES

        -  Compare the effects of the placement of a gastric band with "conventional" treatment of
           obesity on quality of life, body composition and parameters of the metabolic syndrome.

        -  Identify predictors of "good answer to the ring" to determine the best future
           indications.

        -  Study of the gastric tolerance.

      INCLUSION CRITERIA

        1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is
           greater than IMCZ-score > 4 DP> 8 kg

        2. Obesity "common" non-syndromic.

        3. Medical decision of surgical placement of laparoscopic gastric banding.

        4. Adolescent and family who understand and accept the need for medical and surgical follow
           long term.

        5. Adolescent and family who fully understood the oral and written information explaining
           the study and the need for prolonged follow-up.

        6. Obtention of oral and written consent of the adolescent and the parents.

        7. Parents and adolescents affiliated with the social security system.

      NONINCLUSION CRITERIA

        1. Intellectual Deficit.

        2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.

        3. Obesity with severe binge eating.

        4. Pregnancy or wishes of pregnancy in the following year.

        5. Non accession adolescent and / or family in the process of medical care before
           inclusion.

        6. Predictable post surgical monitoring difficulties.

        7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.

        8. Participation in a clinical study evaluating a treatment during the 2 years of the
           study.

      EXCLUSION CRITERIA

        1. Anesthetic contre indication for placement of a gastric laparoscopic.

        2. IMC> 50 kg/m2 the day of inclusion.

      STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient
      and his family. Patients will then be enrolled and randomized. Patients in group A (surgery
      group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in
      group B start conventional monitoring dietary medical and physical. For both groups follow-up
      visits will occur every 3 months for 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMIZ-score evolution in 2 years.
time frame: 2 years
measure: Evolution of quality of life scales
time frame: 1, 2, 5 and 10 years
measure: Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
time frame: 1 year
measure: Evolution of BMIZ-score
time frame: 1, 5 and 10 years
measure: Evolution of round-waist
time frame: 1, 2, 5 and 10 years
measure: Evolution of bodily composition.
time frame: 1, 2, 5 and 10 years
measure: Evolution of metabolic syndrome parameters.
time frame: 1, 2, 5 and 10 years
measure: Evolution of respiratory parameters: polysomnography
time frame: 2 years
measure: Determination of success factors of the ring.
time frame: 2 years
measure: Study of tolerance of the gastric ring.
time frame: 1, 2, 5 and 10 years
arm group label: gastric ring surgery
arm group type: Experimental
description: in this group a gastric ring will be put by surgery.
arm group label: nutritional help
arm group type: Active Comparator
description: the usual treatment of obesity in France with nutritional care will be dispensed for this arm
intervention type: Procedure
intervention name: gastric ring surgery
arm group label: gastric ring surgery
intervention type: Other
intervention name: nutritional help
arm group label: nutritional help
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
last name: REGIS COUTANT
role: Principal Investigator
affiliation: UNIVERSITY HOSPITAL OF ANGERS
last name: REGIS COUTANT
email: recoutant@chu-angers.fr
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country: France
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Morbid