<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/NCT02973867</url>
  </required_header>
  <id_info>
    <org_study_id>UF9768</org_study_id>
    <nct_id>NCT02973867</nct_id>
  </id_info>
  <brief_title>Myokines Role During Obesity</brief_title>
  <acronym>Bonamy</acronym>
  <official_title>Myokines Role in Bone Mineral Density Increase During Obesity</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We showed, for the first time, that Z-score increase during obesity was dependent on sex,&#xD;
      severity of obesity and age but also on the bone site. Although the increase in BMD at&#xD;
      bearing areas seems to be logically explained by the assumption that mechanical stresses have&#xD;
      an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in&#xD;
      BMD at non-load bearing areas such as the radius. These results suggest that changes in&#xD;
      certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover,&#xD;
      the fact that the BMD or Z score is positively and only correlated with muscle mass and not&#xD;
      with fat mass confirm that mechanical stresses are not the only factors acting on bone&#xD;
      tissue.&#xD;
&#xD;
      Our objectives are to determine the relationship between plasma concentration of myokines,&#xD;
      adipokines, bone markers and BMD in obese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We showed, for the first time, that Z-score increase during obesity was dependent on sex,&#xD;
      severity of obesity and age but also on the bone site. Although the increase in BMD at&#xD;
      bearing areas seems to be logically explained by the assumption that mechanical stresses have&#xD;
      an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in&#xD;
      BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1.&#xD;
      S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds,&#xD;
      induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z&#xD;
      score is positively and only correlated with muscle mass and not with fat mass confirm that&#xD;
      mechanical stresses are not the only factors acting on bone tissue.&#xD;
&#xD;
      Our objectives are to determine the relationship between plasma concentration of myokines,&#xD;
      adipokines, bone markers and BMD in obese subjects.&#xD;
&#xD;
      Our objectives are to determine the relationship between plasma concentration of myokines&#xD;
      (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5,&#xD;
      P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity,&#xD;
      differents ages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>myosin concentration</measure>
    <time_frame>1 day</time_frame>
    <description>blood measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adipokines concentration</measure>
    <time_frame>1 day</time_frame>
    <description>blood measure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Obesity, Adolescent</condition>
  <arm_group>
    <arm_group_label>Cohort called Elodie</arm_group_label>
    <description>Obese patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        obese patients&#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>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SULTAN ARIANE</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>SULTAN ARIANE</last_name>
    <phone>467338402</phone>
    <phone_ext>33</phone_ext>
    <email>a-sultan@chu-montpellier.fr</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 24, 2016</last_update_submitted>
  <last_update_submitted_qc>November 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone mineral density</keyword>
  <keyword>Myokines</keyword>
  <keyword>Adipokines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <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/NCT02973867
org study id: UF9768
nct id: NCT02973867
lead sponsor: 
has dmc: Yes
We showed, for the first time, that Z-score increase during obesity was dependent on sex,
      severity of obesity and age but also on the bone site. Although the increase in BMD at
      bearing areas seems to be logically explained by the assumption that mechanical stresses have
      an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in
      BMD at non-load bearing areas such as the radius. These results suggest that changes in
      certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover,
      the fact that the BMD or Z score is positively and only correlated with muscle mass and not
      with fat mass confirm that mechanical stresses are not the only factors acting on bone
      tissue.

      Our objectives are to determine the relationship between plasma concentration of myokines,
      adipokines, bone markers and BMD in obese subjects.
We showed, for the first time, that Z-score increase during obesity was dependent on sex,
      severity of obesity and age but also on the bone site. Although the increase in BMD at
      bearing areas seems to be logically explained by the assumption that mechanical stresses have
      an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in
      BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1.
      S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds,
      induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z
      score is positively and only correlated with muscle mass and not with fat mass confirm that
      mechanical stresses are not the only factors acting on bone tissue.

      Our objectives are to determine the relationship between plasma concentration of myokines,
      adipokines, bone markers and BMD in obese subjects.

      Our objectives are to determine the relationship between plasma concentration of myokines
      (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5,
      P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity,
      differents ages.
observational model: Cohort
time perspective: Retrospective
measure: myosin concentration
time frame: 1 day
description: blood measure
measure: adipokines concentration
time frame: 1 day
description: blood measure
arm group label: Cohort called Elodie
description: Obese patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: SULTAN ARIANE
role: Study Director
affiliation: University Hospital, Montpellier
last name: SULTAN ARIANE
phone: 467338402
phone ext: 33
email: a-sultan@chu-montpellier.fr
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Undecided