<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/NCT04493814</url>
  </required_header>
  <id_info>
    <org_study_id>2019PI279</org_study_id>
    <nct_id>NCT04493814</nct_id>
  </id_info>
  <brief_title>Study Visceral Adipose Tissue and Liver Stifness in a Retrospective Cohort of Diabetes Mellitus Patients</brief_title>
  <official_title>Study of Association Between Quantity (and Percentage) of Visceral Adipose Tissue and NAFLD-linked Liver Stifness as Mesured by Fibroscan in a Retrospective Cohort of Diabetes Mellitus Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non Alcoholic Fatty Liver Disease (NAFLD) is an emergent disease worldwide, and soon the&#xD;
      leading cause of hepatic transplant in the USA. Among this high number of patients, the&#xD;
      current challenge is to detect or even predict patients at risk of inflammation (Non&#xD;
      Alcoholic or Steatohepatitis or NASH) and end-stage fibrosis, which are the best predictors&#xD;
      of liver-related mortality.&#xD;
&#xD;
      Visceral obesity is intimately associated with metabolic disease and adverse health outcomes,&#xD;
      such as diabetes, and NAFLD. It has been demonstrated that visceral adipose tissue-linked&#xD;
      inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related&#xD;
      complications.&#xD;
&#xD;
      The aim of this study was to evaluate the association of the quantity and percentage of&#xD;
      Visceral Adipose Tissue by Dual X-Ray Absorptiometry and liver stiffness by Fibroscan in&#xD;
      patients with type 2 diabetes, and other predictors of fibrosis such as FIB-4 and Fibrotest.&#xD;
      We retrospectively collected the data of all the diabetic patients who had undergone a DEXA&#xD;
      and a Fibroscan between January 1st, 2014 and Decembre 31th, 2019, in the Universitary&#xD;
      Hospital of Nancy, France.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Association between quantity of Visceral adipose Tissu and Liver Stiffness</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu in grams mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between percentage of Visceral adipose Tissu and Liver Stiffness</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu in percentage on total fat mass mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between quantity of Visceral adipose Tissue and histologic Fibrosis</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between percentage of Visceral adipose Tissue and histologic Fibrosis</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the diagnostic performances of quantity of Visceral adipose Tissue for histologic fibrosis diagnosis.</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the diagnostic performances of percentage of Visceral adipose Tissue for histologic fibrosis diagnosis.</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Histologic fibrosis determined on hepatic biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Build an algorithm with Visceral adipose Tissue mesured and biological markers to predict fibrosis.</measure>
    <time_frame>July to September 2020</time_frame>
    <description>Prediction algorithm for hepatic fibrosis based on different markers</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">86</enrollment>
  <condition>NAFLD</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>All the patients with type 2 diabetes followed at Universitary Hospital of Nancy who had undergone a DEXA and a Fibroscan between 2014 and 2019.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients with type 2 diabetes, followed and Universitary Hospital of Nancy, France,&#xD;
        who had undergone a DEXA and a VCTE examination during their care path, in less than a year&#xD;
        apart, between 2014 and 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  Patients who had undergone a VCTE examen at Universitary Hospital of Nancy between&#xD;
             January 1st, 2014 and December 31th, 2019&#xD;
&#xD;
          -  - Patients who had undergone a DEXA at Universitary Hospital of Nancy with less than&#xD;
             one year of difference with VCTE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Viral, ethylic, drug-linked, genetic, self-immune hepatitis, liver cancer or metatasis&#xD;
             ; other causes who could interact with fibroscan or biological markers&#xD;
             (thrombocytopenia, undernutrition)&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Weight variation (&gt;5% of body weight) between DEXA mesure and Fibroscan mesure&#xD;
&#xD;
          -  Fail of VCTE examination&#xD;
&#xD;
          -  High alcohol consumption (&gt;30g/day for men and &gt;20g.day for women)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Other causes of secondary hepatic steatosis (drug-linked, parenteral nutrition, rare&#xD;
             diseases...)&#xD;
&#xD;
          -  Any other pathology that the investigator would consider not compatible with the&#xD;
             research&#xD;
&#xD;
          -  Patients in any other research protocol three months before inclusion&#xD;
&#xD;
          -  Person referred as in the Public Health code (articles L.1121-5, L.1121-7 and&#xD;
             L.1121-8) : pregnant or nursing woman, minor adult, major adult under legal&#xD;
             protection, adult unable of giving consent&#xD;
&#xD;
          -  Person deprived of their liberty by judicial or administrative decision, person under&#xD;
             psychiatric care as described in articles L. 3212-1 and L.3213-1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>GUERCI Bruno</name>
      <address>
        <city>Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>NASH</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Visceral Adipose Tissue</keyword>
  <keyword>DXA</keyword>
  <keyword>Fibroscan</keyword>
  <keyword>Vibration-Controlled Transient Elastography</keyword>
  <keyword>Liver cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04493814
org study id: 2019PI279
nct id: NCT04493814
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Non Alcoholic Fatty Liver Disease (NAFLD) is an emergent disease worldwide, and soon the
      leading cause of hepatic transplant in the USA. Among this high number of patients, the
      current challenge is to detect or even predict patients at risk of inflammation (Non
      Alcoholic or Steatohepatitis or NASH) and end-stage fibrosis, which are the best predictors
      of liver-related mortality.

      Visceral obesity is intimately associated with metabolic disease and adverse health outcomes,
      such as diabetes, and NAFLD. It has been demonstrated that visceral adipose tissue-linked
      inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related
      complications.

      The aim of this study was to evaluate the association of the quantity and percentage of
      Visceral Adipose Tissue by Dual X-Ray Absorptiometry and liver stiffness by Fibroscan in
      patients with type 2 diabetes, and other predictors of fibrosis such as FIB-4 and Fibrotest.
      We retrospectively collected the data of all the diabetic patients who had undergone a DEXA
      and a Fibroscan between January 1st, 2014 and Decembre 31th, 2019, in the Universitary
      Hospital of Nancy, France.
observational model: Cohort
time perspective: Retrospective
measure: Association between quantity of Visceral adipose Tissu and Liver Stiffness
time frame: July to September 2020
description: Visceral adipose tissu in grams mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography
measure: Association between percentage of Visceral adipose Tissu and Liver Stiffness
time frame: July to September 2020
description: Visceral adipose tissu in percentage on total fat mass mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography
measure: Association between quantity of Visceral adipose Tissue and histologic Fibrosis
time frame: July to September 2020
description: Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.
measure: Association between percentage of Visceral adipose Tissue and histologic Fibrosis
time frame: July to September 2020
description: Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.
measure: Determine the diagnostic performances of quantity of Visceral adipose Tissue for histologic fibrosis diagnosis.
time frame: July to September 2020
description: Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.
measure: Determine the diagnostic performances of percentage of Visceral adipose Tissue for histologic fibrosis diagnosis.
time frame: July to September 2020
description: Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.
measure: Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.
time frame: July to September 2020
description: Histologic fibrosis determined on hepatic biopsy.
measure: Build an algorithm with Visceral adipose Tissue mesured and biological markers to predict fibrosis.
time frame: July to September 2020
description: Prediction algorithm for hepatic fibrosis based on different markers
arm group label: Cohort
description: All the patients with type 2 diabetes followed at Universitary Hospital of Nancy who had undergone a DEXA and a Fibroscan between 2014 and 2019.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided