Status:
RECRUITING
German SLD-Registry (Deutsches SLD-Register)
Lead Sponsor:
Leberstiftungs-GmbH Deutschland
Conditions:
Steatotic Liver Disease
Eligibility:
All Genders
18+ years
Brief Summary
Characterization of patients with steatotic liver disease (SLD) The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Lebersti...
Detailed Description
The following data can be documented: * physical examination and vital parameters (e.g. age, weight) * comorbidities (e.g. diabetes mellitus, cardiovascular disease) * comedication (treatment of como...
Eligibility Criteria
Inclusion
- diagnosed SLD based on the following criteria:
- typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
- Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
- Evaluation of metabolic syndrome
- credible assessment of alcohol consumption
- written informed consent
Exclusion
- patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin
- patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake)
- malignant disease with a life expectancy \<12 months
- participation in clinical interventional/pivotal studies
- inability to provide written informed consent
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2036
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04721665
Start Date
December 1 2020
End Date
November 30 2036
Last Update
March 6 2025
Active Locations (14)
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1
Infektiologisches Zentrum Steglitz
Berlin, Germany
2
Leber- und Studienzentrum Checkpoint
Berlin, Germany
3
MVZ für Gastroenterologie am Bayerischen Platz
Berlin, Germany
4
Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
Berlin, Germany