German SLD-Registry (Deutsches SLD-Register)

German Liver Foundation

Status: Enrolling

Conditions: Steatotic Liver Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04721665

NAFLD_01

Details and patient eligibility

About

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).

Full 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)

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

SLD patients

Description:

No intervention