German SLD-Registry (Deutsches SLD-Register)

Last updated: March 4, 2025
Sponsor: Leberstiftungs-GmbH Deutschland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT04721665
NAFLD_01
  • Ages > 18
  • All Genders

Study 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 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosed SLD based on the following criteria:

  1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathologicalCAP value (latter is optional)

  2. Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/ortransient elastography

  3. Evaluation of metabolic syndrome

  • credible assessment of alcohol consumption

  • written informed consent

Exclusion

Exclusion Criteria:

  • patients with other hepatologic diseases (chronically viral, metabolic, autoimmuneorigin

  • 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 Design

Total Participants: 5000
Study Start date:
December 01, 2020
Estimated Completion Date:
November 30, 2036

Study 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)

Connect with a study center

  • Infektiologisches Zentrum Steglitz

    Berlin,
    Germany

    Active - Recruiting

  • Leber- und Studienzentrum Checkpoint

    Berlin,
    Germany

    Active - Recruiting

  • MVZ für Gastroenterologie am Bayerischen Platz

    Berlin,
    Germany

    Active - Recruiting

  • Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer

    Berlin,
    Germany

    Active - Recruiting

  • Praxis Ludwig und Dikopoulos

    Dornstadt,
    Germany

    Active - Recruiting

  • Fachinternistische Schwerpunktpraxis

    Hamburg,
    Germany

    Active - Recruiting

  • Gastroenterologische Studiengesellschaft Herne

    Herne,
    Germany

    Active - Recruiting

  • Leberstudienzentrum Kiel

    Kiel,
    Germany

    Active - Recruiting

  • MVZ Viszeralmedizin GmbH

    Köln,
    Germany

    Active - Recruiting

  • Eugastro GmbH

    Leipzig,
    Germany

    Active - Recruiting

  • MVZ Dres. Eisenbach,Simon, Schwarz GbR

    Leverkusen,
    Germany

    Active - Recruiting

  • Praxis Dr. med. Kerstin Stein

    Magdeburg,
    Germany

    Active - Recruiting

  • CIM GmbH

    Münster,
    Germany

    Active - Recruiting

  • St. Josefs-Hospital Medizinische Klinik II

    Wiesbaden,
    Germany

    Active - Recruiting

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