<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/NCT03755323</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0322</org_study_id>
    <nct_id>NCT03755323</nct_id>
  </id_info>
  <brief_title>Establishment of a Database of Patients Suffering From Obesity With a Medical Treatment</brief_title>
  <acronym>Elodie Cohort</acronym>
  <official_title>Establishment of a Database of Patients Suffering From Obesity With a Medical Treatment in the Framework of The Specialized Obesity Center Languedoc-Roussillon CHU Montpellier</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Obesity is a public health problem, given its prevalence (15% in France in 2012, Obépi&#xD;
      survey) but also by the complications that it generates. We were firstly, intersted in bone&#xD;
      mineral density during obesity.&#xD;
&#xD;
      We were able to confirm in an observational study that BMD (Z-score)was augmented. We also&#xD;
      showed, for the first time, that this increase in Z-score was dependent on sex, severity of&#xD;
      obesity and age but also bone site. If the increase in BMD at the level of the bearing zones&#xD;
      seems logically to be explained by the hypothesis that the mechanical stresses have an&#xD;
      osteogenic effect on the bone tissue, the latter can not in any way respond to the&#xD;
      concomitant increase in BMD at non-bearing areas such as the radius.These results suggest&#xD;
      that changes in certain systemic compounds induced by obesity may interfere with bone&#xD;
      metabolism. recent data also suggest a change in the concentration of pro-glucagon peptides&#xD;
      (GLP-1, glicentin, glucagon, etc.) in obese subjects and in bariatric surgery). Although body&#xD;
      composition and its variation after surgery could be largely involved in the modification of&#xD;
      these peptides, no data on these potential relationships is currently available. However, no&#xD;
      data are available for baseline body composition and weight loss data. Finally, 80% of&#xD;
      obesity is associated with insulin resistance, a key mechanism in the pathophysiology of type&#xD;
      2 diabetes. A metabolically healthy obesity phenotype is described, although the definition&#xD;
      criteria are not consensual.The evolution of this phenotype with aging and with the duration&#xD;
      of evolution of obesity is not well described.&#xD;
&#xD;
      Our goal is to create a database of weight-bearing patients in the care setting and to&#xD;
      determine the &quot;hormonal dialogue&quot; between peripheral (muscular and adipose) and bone tissues,&#xD;
      which may be associated with changes in body composition during obesity and aging, and that&#xD;
      according to sex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>identify the determinants of body composition</measure>
    <time_frame>1 day</time_frame>
    <description>Compile a comprehensive database of all patients who are weight-bearing as part of the care to identify the determinants of body composition (lean mass, bone mass, muscle mass) in the obese subject according to sex and age, and the link with the complications of obesity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measured plasma concentration</measure>
    <time_frame>1 day</time_frame>
    <description>Measured plasma concentration of myokines, adipokines, markers of bone remodeling, incretin-glucagon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measurement of muscle strength</measure>
    <time_frame>1 day</time_frame>
    <description>the measurement of muscle strength by hand-grip and performance by 6-minute walk test.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>BMI Greater Than 30</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects older than 18 years (BMI greater than 30). These patients are seen in consultation&#xD;
        with a request for weight management carried out in the cade care , in the framework of The&#xD;
        Specialized Obesity Center Languedoc-Roussillon CHU Montpellier&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - obese patients age above 18 years old&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - non agreement of inclusion&#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>Ariane SULTAN, PR</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ariane SULTAN, PR</last_name>
    <phone>467338402</phone>
    <phone_ext>33</phone_ext>
    <email>a-sultan@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ariane SULTAN, PR</last_name>
      <phone>467338402</phone>
      <phone_ext>33</phone_ext>
      <email>a-sultan@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Nutrition Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03755323
org study id: RECHMPL18_0322
nct id: NCT03755323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is a public health problem, given its prevalence (15% in France in 2012, Obépi
      survey) but also by the complications that it generates. We were firstly, intersted in bone
      mineral density during obesity.

      We were able to confirm in an observational study that BMD (Z-score)was augmented. We also
      showed, for the first time, that this increase in Z-score was dependent on sex, severity of
      obesity and age but also bone site. If the increase in BMD at the level of the bearing zones
      seems logically to be explained by the hypothesis that the mechanical stresses have an
      osteogenic effect on the bone tissue, the latter can not in any way respond to the
      concomitant increase in BMD at non-bearing areas such as the radius.These results suggest
      that changes in certain systemic compounds induced by obesity may interfere with bone
      metabolism. recent data also suggest a change in the concentration of pro-glucagon peptides
      (GLP-1, glicentin, glucagon, etc.) in obese subjects and in bariatric surgery). Although body
      composition and its variation after surgery could be largely involved in the modification of
      these peptides, no data on these potential relationships is currently available. However, no
      data are available for baseline body composition and weight loss data. Finally, 80% of
      obesity is associated with insulin resistance, a key mechanism in the pathophysiology of type
      2 diabetes. A metabolically healthy obesity phenotype is described, although the definition
      criteria are not consensual.The evolution of this phenotype with aging and with the duration
      of evolution of obesity is not well described.

      Our goal is to create a database of weight-bearing patients in the care setting and to
      determine the "hormonal dialogue" between peripheral (muscular and adipose) and bone tissues,
      which may be associated with changes in body composition during obesity and aging, and that
      according to sex.
observational model: Cohort
time perspective: Prospective
measure: identify the determinants of body composition
time frame: 1 day
description: Compile a comprehensive database of all patients who are weight-bearing as part of the care to identify the determinants of body composition (lean mass, bone mass, muscle mass) in the obese subject according to sex and age, and the link with the complications of obesity.
measure: Measured plasma concentration
time frame: 1 day
description: Measured plasma concentration of myokines, adipokines, markers of bone remodeling, incretin-glucagon
measure: measurement of muscle strength
time frame: 1 day
description: the measurement of muscle strength by hand-grip and performance by 6-minute walk test.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ariane SULTAN, PR
role: Study Director
affiliation: University Hospital, Montpellier
last name: Ariane SULTAN, PR
phone: 467338402
phone ext: 33
email: a-sultan@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: Undecided
ipd description: NC