Influence of Adiponutrin in Chronic Liver Disease

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01122797
First received: May 11, 2010
Last updated: NA
Last verified: December 2002
History: No changes posted
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122797

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

Publications:

Additional 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
Study First Received: May 11, 2010
Last Updated: May 11, 2010
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014