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Influence of Adiponutrin in Chronic Liver Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122797
First Posted: May 13, 2010
Last Update Posted: May 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erasme University Hospital
  Purpose
Increasing evidence attests the influence of multiple metabolic genetic risk factors in the progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as lipid peroxidation and cytokines have been implicated in promoting inflammation leading to fibrosis increase and liver injury progression. The aim of this study was to assess the role of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease patients.

Condition
Alcoholic Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of Metabolism Influence in Human Alcoholic Liver Disease

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Assessment of fibrosis and steatosis by liver biopsy in alcoholic liver disease patients.
    After liver histology assessment for liver liver dammage a potential correlation of fibrosis and steatosis was studied with rs738409 PNPLA3 polymorphism


Biospecimen Retention:   Samples With DNA
DNA extraction from whole blood sample. Piece of liver tissue in the alcoholic liver disease group.

Enrollment: 658
Study Start Date: January 2003
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alcoholic liver disease
Alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution
Controls
Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Consecutive patients undergoing transjugular liver biopsy for alcoholic liver disease will be included in the study to determine the potential correlation between rs738409 PNPLA3 polymorphism and/or PNPLA3 mRNA expression.
Criteria

ALD patients:

Inclusion Criteria:

  • Excess alcohol intake
  • Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or a suspicion of cirrhosis related to ALD
  • Caucasian ethnicity

Exclusion Criteria:

  • Presence of any other chronic liver disease
  • Co-infection with human immunodeficiency virus

Controls:

Inclusion Criteria:

  • Caucasian ethnicity

Exclusion Criteria:

  • Presence of a disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122797


Locations
Belgium
Hopital Erasme- Dpt of Gastroenterology
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Trépo, MD, Erasme University Hospital (Olivier Le Moine, MD, PhD)
ClinicalTrials.gov Identifier: NCT01122797     History of Changes
Other Study ID Numbers: ET-PNPLA3
First Submitted: May 11, 2010
First Posted: May 13, 2010
Last Update Posted: May 13, 2010
Last Verified: December 2002

Keywords provided by Erasme University Hospital:
PNPLA3
fibrosis
cirrhosis
alcoholic liver disease

Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders