- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575133
Prospective Cohort Study in Patients With NAFLD
February 23, 2012 updated by: University of Zurich
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oliver Tschopp
- Phone Number: +41 (0)44 255 11 11
- Email: oliver.tschopp@usz.ch
Study Contact Backup
- Name: Giatgen Spinas, Professor, MD
- Email: giatgen.spinas@usz.ch
Study Locations
-
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ZH
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Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Endocrinology and Diabetology
-
Contact:
- Oliver Tschopp, MD
- Email: oliver.tschopp@usz.ch
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with non-alcoholic fatty liver disease
Description
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).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease regression/progression
Time Frame: 20 years
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giatgen Spinas, Prof. MD, University Hospital Zurich, Endocrinology and Diabetology
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
December 1, 2007
Study Completion (Anticipated)
November 1, 2027
Study Registration Dates
First Submitted
November 26, 2007
First Submitted That Met QC Criteria
December 17, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Estimate)
February 24, 2012
Last Update Submitted That Met QC Criteria
February 23, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-1450
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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