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Prospective Cohort Study in Patients With NAFLD
This study is currently recruiting participants.
Verified by University of Zurich, November 2007
First Received: November 26, 2007   Last Updated: June 25, 2008   History of Changes
Sponsored by: University of Zurich
Information provided by: University of Zurich
ClinicalTrials.gov Identifier: NCT00575133
  Purpose

To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.


Condition
Non-Alcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Multicentric, Prospective, Non-Interventional, Long-Term Cohort Study in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Disease regression/progression [ Time Frame: 20 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Liver biopsy


Estimated Enrollment: 150
Study Start Date: December 2007
Estimated Study Completion Date: November 2027
Detailed Description:

Patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with NAFLD (see exclusion criteria). Of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained.

In addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. In case of high clinical, laboratory and radiological suspicion for NAFLD, a diagnostic liver biopsy will be performed. A part of the liver tissue is used for histological confirmation of NAFLD and subsequent grading and staging according established criteria. Parts of the remaining liver tissue will be stored for later molecular and histological analysis. In addition, several serum samples are collected of patients and stored for future analysis. All patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis.

Liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-alcoholic fatty liver disease

Criteria

Inclusion criteria:

  • Patients with histologically confirmed fatty liver disease

Exclusion criteria:

  • History of significant alcohol consumption
  • Viral hepatitis
  • Autoimmune hepatitis
  • Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
  • Hepatotoxic medication (e.g. amiodarone).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575133

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland
Contact: Oliver Tschopp, MD         oliver.tschopp@usz.ch    
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University Hospital Zurich ( Oliver Tschopp )
Study ID Numbers: EK-1450
Study First Received: November 26, 2007
Last Updated: June 25, 2008
ClinicalTrials.gov Identifier: NCT00575133     History of Changes
Health Authority: Switzerland: Swissmedic

Study placed in the following topic categories:
Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on September 11, 2009