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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00575133 |
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 |
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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) |
Liver biopsy
Estimated Enrollment: | 150 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2027 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with non-alcoholic fatty liver disease
Inclusion criteria:
Exclusion criteria:
Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 |
Switzerland | |
University Hospital Zurich | Recruiting |
Zurich, Switzerland | |
Contact: Oliver Tschopp, MD oliver.tschopp@usz.ch |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
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 |
Liver Diseases Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver |
Liver Diseases Digestive System Diseases Fatty Liver |