Influence of Adiponutrin in Chronic Liver Disease

May 11, 2010 updated by: Erasme University Hospital

Study of Metabolism Influence in Human Alcoholic Liver Disease

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme- Dpt of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2010

Last Update Submitted That Met QC Criteria

May 11, 2010

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET-PNPLA3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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