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

November 26, 2007
June 25, 2008
December 2007
 
Disease regression/progression [ Time Frame: 20 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575133 on ClinicalTrials.gov Archive Site
 
 
 
Prospective Cohort Study in Patients With NAFLD
Multicentric, Prospective, Non-Interventional, Long-Term Cohort Study in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

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.

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.

 
Observational
Cohort, Prospective
Non-Alcoholic Fatty Liver Disease
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
November 2027
 

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).
Both
18 Years and older
No
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT00575133
Oliver Tschopp, University Hospital Zurich
EK-1450
University of Zurich
 
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP