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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Limoges, Frankrig, 87025
- Centre Hospitalier Esquirol
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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alkoholabstinenser
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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)
Tidsramme: 6 months maximum
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6 months maximum
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Tidsramme: 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
Tidsramme: 6 months
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6 months
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Variations in liver stiffness
Tidsramme: 6 months
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6 months
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controlled attenuation parameter (CAP) at each follow-up
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2014-A00854-43
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