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

January 30, 2017 updated by: Philippe Nubukpo, Centre Hospitalier Esquirol

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87025
        • Centre Hospitalier Esquirol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

alcohol-dependent subjects hospitalized for alcohol withdrawal

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
alcohol withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months maximum

Secondary Outcome Measures

Outcome Measure
Time Frame
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Time Frame: 6 months
6 months
liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
Time Frame: 6 months
6 months
Variations in liver stiffness
Time Frame: 6 months
6 months
controlled attenuation parameter (CAP) at each follow-up
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Esquirol

Collaborators

Hôpital Dupuytren

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-A00854-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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