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

NCT ID: NCT02202148

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Withdrawal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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alcohol withdrawal

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Dupuytren

OTHER

Sponsor Role collaborator

Centre Hospitalier Esquirol

OTHER

Sponsor Role lead

Responsible Party

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Philippe Nubukpo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Nubukpo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Esquirol

Locations

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Centre Hospitalier Esquirol

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00854-43

Identifier Type: -

Identifier Source: org_study_id

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