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Completed

NCT Number: NCT02202148

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

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.

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Key information

Conditions

Alcohol Withdrawal Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Esquirol

Limoges, 87025, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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)

    Time frame: 6 months maximum

Secondary outcomes

  1. serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.

    Time frame: 6 months

  2. liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6

    Time frame: 6 months

  3. Variations in liver stiffness

    Time frame: 6 months

  4. controlled attenuation parameter (CAP) at each follow-up

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Collaborators

  • Hôpital Dupuytren

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2014
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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