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Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

Sponsor
Centre Hospitalier Esquirol (Other)
Overall Status
Completed
CT.gov ID
NCT02202148
Collaborator
Hôpital Dupuytren (Other)
195
Enrollment
1
Location
17.1
Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    195 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    alcohol withdrawal

    Outcome Measures

    Primary Outcome Measures

    1. 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) [6 months maximum]

    Secondary Outcome Measures

    1. serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6. [6 months]

    2. liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6 [6 months]

    3. Variations in liver stiffness [6 months]

    4. controlled attenuation parameter (CAP) at each follow-up [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)

    • criteria from the main study

    Exclusion Criteria:
    • criteria from the main study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Esquirol Limoges France 87025

    Sponsors and Collaborators

    • Centre Hospitalier Esquirol
    • Hôpital Dupuytren

    Investigators

    • Principal Investigator: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
    ClinicalTrials.gov Identifier:
    NCT02202148
    Other Study ID Numbers:
    • 2014-A00854-43
    First Posted:
    Jul 28, 2014
    Last Update Posted:
    Jan 31, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
    Fibroscan
    alcohol dependence
    alcohol withdrawal
    controlled attenuation parameter
    BDNF

    Study Results

    No Results Posted as of Jan 31, 2017