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

NCT02202148 | Completed

• 1 other identifier: 2014-A00854-43
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal

Keywords

Fibroscan; alcohol dependence; alcohol withdrawal; controlled attenuation parameter; BDNF

Outcome Measures

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)

  6 months maximum

Secondary Outcomes (4)

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

  6 months

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

  6 months

• Variations in liver stiffness

  6 months

• controlled attenuation parameter (CAP) at each follow-up

  6 months

Study Arms (1)

alcohol withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

alcohol-dependent subjects hospitalized for alcohol withdrawal

You may qualify if:

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

You may not qualify if:

• criteria from the main study

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead
• Hôpital Dupuytren: collaborator

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Philippe Nubukpo, MD, PhD

  Centre Hospitalier Esquirol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 28, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

FR (1)