<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/NCT03302481</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0055</org_study_id>
    <nct_id>NCT03302481</nct_id>
  </id_info>
  <brief_title>Mitochondrial Metabolism and Hepatic Complications of Obesity</brief_title>
  <acronym>DMSO</acronym>
  <official_title>Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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 study aims to characterize mitochondrial metabolism in the liver of obesity surgery&#xD;
      patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to characterize mitochondrial metabolism in the liver of obesity surgery&#xD;
      patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.&#xD;
      The protocols involves a per-operative hepatic needle biopsy for mitochondria&#xD;
      characterization and histological scoring of steatosis, inflammation, and fibrosis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no ethic committee autorization&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Association between nonalcoholic steato-hepatitis and mitochondria morphological markers</measure>
    <time_frame>Until 6 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>liver biopsy</intervention_name>
    <description>the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult men and women&#xD;
&#xD;
          -  affiliated to a social security&#xD;
&#xD;
          -  candidate for laparoscopic obesity surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excessive alcohol consumption:&gt; 20 g / day (woman),&gt; 30 g / day (male)&#xD;
&#xD;
          -  Chronic viral hepatitis B or C&#xD;
&#xD;
          -  Genetic hemochromatosis&#xD;
&#xD;
          -  Taking the following drugs for at least 3 months up to 6 months before the scheduled&#xD;
             date of obesity surgery: systemic corticosteroids, amiodarone, methotrexate&#xD;
&#xD;
          -  Wilson's disease&#xD;
&#xD;
          -  autoimmune hepatitis&#xD;
&#xD;
          -  alpha 1-antitrypsin deficiency&#xD;
&#xD;
          -  abetalipoproteinemia&#xD;
&#xD;
          -  Contraindications to liver biopsy&#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>David JACOBI, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity surgery</keyword>
  <keyword>liver</keyword>
  <keyword>mitochondria</keyword>
  <keyword>steatosis</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>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/NCT03302481
org study id: RC17_0055
nct id: NCT03302481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to characterize mitochondrial metabolism in the liver of obesity surgery
      patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.
The study aims to characterize mitochondrial metabolism in the liver of obesity surgery
      patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.
      The protocols involves a per-operative hepatic needle biopsy for mitochondria
      characterization and histological scoring of steatosis, inflammation, and fibrosis
allocation: N/A
intervention model: Single Group Assignment
intervention model description: patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
primary purpose: Other
masking: None (Open Label)
measure: Association between nonalcoholic steato-hepatitis and mitochondria morphological markers
time frame: Until 6 month
arm group label: Experimental Group
arm group type: Experimental
description: the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
intervention type: Other
intervention name: liver biopsy
description: the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David JACOBI, Dr
role: Principal Investigator
affiliation: Nantes University Hospital
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No