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German SLD-Registry (Deutsches SLD-Register)

German SLD-Registry (Deutsches SLD-Register)

Recruiting
18 years and older
All
Phase N/A

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Overview

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 Leberstiftungs-GmbH Deutschland.

The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).

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 comorbidities related to SLD)
  • laboratory values (e.g. liver function tests, creatinine)
  • genetic variants (e.g. PNPLA3)
  • liver diagnostics (e.g. histological findings, sonographic findings)
  • lifestyle (alcohol consumption, physical activity)
  • health related quality of life (SF-36 questionnaire)

Eligibility

Inclusion Criteria:

  • diagnosed SLD based on the following criteria:
    1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
    2. Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
    3. Evaluation of metabolic syndrome
  • credible assessment of alcohol consumption
  • written informed consent

Exclusion Criteria:

  • 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

Study details
    Steatotic Liver Disease

NCT04721665

Leberstiftungs-GmbH Deutschland

26 January 2024

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