<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/NCT02202148</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00854-43</org_study_id>
    <nct_id>NCT02202148</nct_id>
  </id_info>
  <brief_title>Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Esquirol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hôpital Dupuytren</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Esquirol</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is complementary to the main study &quot;Brain Derived Neurotrophic Factor Serum Levels&#xD;
      Evolution During the Six Months After Alcohol Withdrawal &quot; NCT01491347.&#xD;
&#xD;
      Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption.&#xD;
      It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to&#xD;
      depend on alcohol consumption in alcohol dependent patient, more precisely on the time after&#xD;
      the last alcohol consumption. This is very few documented after alcohol withdrawal, and has&#xD;
      never been explored during several months after withdrawal as a function of alcohol&#xD;
      consumption and abstinence.&#xD;
&#xD;
      Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis&#xD;
      and also liver function.&#xD;
&#xD;
      We propose here to analyse the serum BDNF levels variations after withdrawal according to&#xD;
      liver stiffness levels and alcohol consumption status.&#xD;
&#xD;
      We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included&#xD;
      in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28&#xD;
      and months 2, 4, and 6.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>BDNF serum levels as a function of stiffness categories in the abstinent and non abstinent groups at inclusion and at the different follow-ups of the study (M2, M4, M6)</measure>
    <time_frame>6 months maximum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in liver stiffness</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>controlled attenuation parameter (CAP) at each follow-up</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">195</enrollment>
  <condition>Alcohol Withdrawal</condition>
  <arm_group>
    <arm_group_label>alcohol withdrawal</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        alcohol-dependent subjects hospitalized for alcohol withdrawal&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participation to the study &quot;BDNF serum levels evolution during 6 months after alcohol&#xD;
             withdrawal&quot; (main study)&#xD;
&#xD;
          -  criteria from the main study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  criteria from the main study&#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>Philippe Nubukpo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Esquirol</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Esquirol</name>
      <address>
        <city>Limoges</city>
        <zip>87025</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Esquirol</investigator_affiliation>
    <investigator_full_name>Philippe Nubukpo</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Fibroscan</keyword>
  <keyword>alcohol dependence</keyword>
  <keyword>alcohol withdrawal</keyword>
  <keyword>controlled attenuation parameter</keyword>
  <keyword>BDNF</keyword>
  <!-- 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/NCT02202148
org study id: 2014-A00854-43
nct id: NCT02202148
lead sponsor: 
collaborator: 
has dmc: No
This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels
      Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

      Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption.
      It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to
      depend on alcohol consumption in alcohol dependent patient, more precisely on the time after
      the last alcohol consumption. This is very few documented after alcohol withdrawal, and has
      never been explored during several months after withdrawal as a function of alcohol
      consumption and abstinence.

      Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis
      and also liver function.

      We propose here to analyse the serum BDNF levels variations after withdrawal according to
      liver stiffness levels and alcohol consumption status.

      We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included
      in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28
      and months 2, 4, and 6.
observational model: Cohort
time perspective: Prospective
measure: BDNF serum levels as a function of stiffness categories in the abstinent and non abstinent groups at inclusion and at the different follow-ups of the study (M2, M4, M6)
time frame: 6 months maximum
measure: serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
time frame: 6 months
measure: liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
time frame: 6 months
measure: Variations in liver stiffness
time frame: 6 months
measure: controlled attenuation parameter (CAP) at each follow-up
time frame: 6 months
arm group label: alcohol withdrawal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Nubukpo, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Esquirol
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Esquirol
investigator full name: Philippe Nubukpo
investigator title: MD, PhD