<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/NCT02264431</url>
  </required_header>
  <id_info>
    <org_study_id>1327</org_study_id>
    <secondary_id>2013-A01097-38</secondary_id>
    <nct_id>NCT02264431</nct_id>
  </id_info>
  <brief_title>Severe Obesity Outcome Network Cohort (SOON)</brief_title>
  <acronym>SOON</acronym>
  <official_title>Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Act For Chronic Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HP2 laboratory INSERM U1042</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Grenoble Alps</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</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 main objective of the study is to identify the determinant of sleep characteristics of&#xD;
      obese patients attempting a tertiary clinical center for obesity management, including&#xD;
      bariatric surgery.&#xD;
&#xD;
      More accurately the questions addressed are:&#xD;
&#xD;
        -  What are the determinants of the sleep habits (sleep duration, chronotype) and of their&#xD;
           evolution&#xD;
&#xD;
        -  What are the determinants of sleep breathing disorders (sleep apnea, obesity&#xD;
           hypoventilation syndrome) and of their evolution&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult obese patients, attempting a tertiary medical center for the management of their&#xD;
      obesity, are asked to participate in a cohort study. Data issued from routine clinical&#xD;
      practice are collected.&#xD;
&#xD;
      Medical history and actual medical condition:&#xD;
&#xD;
        -  Type 2 or type 1 diabetes&#xD;
&#xD;
        -  Dyslipidemia&#xD;
&#xD;
        -  Hypertension&#xD;
&#xD;
        -  Cardiovascular diseases&#xD;
&#xD;
        -  Steatohepatitis/cirrhosis&#xD;
&#xD;
        -  Gastric disorders&#xD;
&#xD;
        -  Nutritional deficiency&#xD;
&#xD;
        -  Obstructive sleep apnea/Obesity hypoventilation syndrome&#xD;
&#xD;
      All patients who do not have a previously known sleep apnea syndrome are evaluated by&#xD;
      nocturnal polygraphy.&#xD;
&#xD;
      Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by&#xD;
      questionnaires.&#xD;
&#xD;
      Patients are asked to provide blood sample to constituate a serum bank and gene bank.&#xD;
&#xD;
      Patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral&#xD;
      fat.&#xD;
&#xD;
      When patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6&#xD;
      months, 12 months after bariatric surgery and yearly after that for at least 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Sleep breathing disorders</measure>
    <time_frame>5 years</time_frame>
    <description>Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep habits</measure>
    <time_frame>5 years</time_frame>
    <description>Evolution of sleep habits during obesity care, especially after bariatric surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Metabolic diseases</measure>
    <time_frame>5 years</time_frame>
    <description>Evolution of metabolic diseases during obesity care, especially after bariatric surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Other respiratory diseases</measure>
    <time_frame>5 years</time_frame>
    <description>Evolution of other respiratory diseases during obesity care, especially after bariatric surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Complications of bariatric surgery</measure>
    <time_frame>5 years</time_frame>
    <description>Recording of complications after bariatric surgery</description>
  </other_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Obesity</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Sleep</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum bank, gene bank, tissue bank (subcutaneous fat, visceral fat)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with class II or class III obesity (Body mass index ≥ 35kg/m²)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Class II or class III obesity (BMI ≥ 35 kg/m²). Only patients undergoing surgery to&#xD;
             realize a second surgical line of management of their obesity may have a lower BMI, if&#xD;
             the surgical recovery is motivated by a technical defect of the first assembly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate.&#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>Anne-Laure Borel, Pr MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne-Laure Borel, Pr MD PhD</last_name>
    <phone>+33 476 765 509</phone>
    <email>alborel@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu Lesgoirres</last_name>
    <email>mlesgoirres@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <state>Rhône-Alpes</state>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiphaine Montagnon</last_name>
      <phone>+33 4 76 76 68 14</phone>
      <email>tmontagnon@chu-grenoble.fr</email>
    </contact>
    <contact_backup>
      <last_name>Matthieu Lesgoirres</last_name>
      <email>mlesgoirres@chu-grenoble.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Anne-Laure Borel, Pr MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Louis Pépin, Pr MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Catherine Arvieux, Pr MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nelly Wion, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandrine Coumes, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Pierre Zarski, Pr MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Noëlle Hilleret, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Christian Borel, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Renaud Tamisier, Pr MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier Ormezzano, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Sleep Habits</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Obesity</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/NCT02264431
org study id: 1327
secondary id: 2013-A01097-38
nct id: NCT02264431
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to identify the determinant of sleep characteristics of
      obese patients attempting a tertiary clinical center for obesity management, including
      bariatric surgery.

      More accurately the questions addressed are:

        -  What are the determinants of the sleep habits (sleep duration, chronotype) and of their
           evolution

        -  What are the determinants of sleep breathing disorders (sleep apnea, obesity
           hypoventilation syndrome) and of their evolution
Adult obese patients, attempting a tertiary medical center for the management of their
      obesity, are asked to participate in a cohort study. Data issued from routine clinical
      practice are collected.

      Medical history and actual medical condition:

        -  Type 2 or type 1 diabetes

        -  Dyslipidemia

        -  Hypertension

        -  Cardiovascular diseases

        -  Steatohepatitis/cirrhosis

        -  Gastric disorders

        -  Nutritional deficiency

        -  Obstructive sleep apnea/Obesity hypoventilation syndrome

      All patients who do not have a previously known sleep apnea syndrome are evaluated by
      nocturnal polygraphy.

      Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by
      questionnaires.

      Patients are asked to provide blood sample to constituate a serum bank and gene bank.

      Patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral
      fat.

      When patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6
      months, 12 months after bariatric surgery and yearly after that for at least 5 years.
observational model: Cohort
time perspective: Prospective
measure: Sleep breathing disorders
time frame: 5 years
description: Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery
measure: Sleep habits
time frame: 5 years
description: Evolution of sleep habits during obesity care, especially after bariatric surgery
measure: Metabolic diseases
time frame: 5 years
description: Evolution of metabolic diseases during obesity care, especially after bariatric surgery
measure: Other respiratory diseases
time frame: 5 years
description: Evolution of other respiratory diseases during obesity care, especially after bariatric surgery
measure: Complications of bariatric surgery
time frame: 5 years
description: Recording of complications after bariatric surgery
Serum bank, gene bank, tissue bank (subcutaneous fat, visceral fat)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Laure Borel, Pr MD PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
last name: Anne-Laure Borel, Pr MD PhD
phone: +33 476 765 509
email: alborel@chu-grenoble.fr
last name: Matthieu Lesgoirres
email: mlesgoirres@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Obesity
sharing ipd: No