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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Limoges, Frankrike, 87025
- Centre Hospitalier Esquirol
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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alkoholabstinens
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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)
Tidsram: 6 months maximum
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6 months maximum
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Tidsram: 6 months
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6 months
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liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
Tidsram: 6 months
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6 months
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Variations in liver stiffness
Tidsram: 6 months
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6 months
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controlled attenuation parameter (CAP) at each follow-up
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2014-A00854-43
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