German SLD-Registry (Deutsches SLD-Register)

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).

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Key information

Conditions

Steatotic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Infektiologisches Zentrum Steglitz, Berlin, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 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

Treatment and study plan

Primary outcomes

Progression of liver fibrosis

Time frame: through study completion, an average of 1 year

Fibrosis stage is measured by elastography (elastometry kPa value).
Activity of metabolic dysfunction-associated steatohepatitis (MASH)

Time frame: through study completion, an average of 1 year

Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)
Cardiovascular events

Time frame: through study completion, an average of 1 year

The onset of the clinical outcome cardiovascular events (yes/no)
Tumor diseases

Time frame: through study completion, an average of 1 year

The onset of the clinical outcome tumor diseases (yes/no)

Sponsors and collaborators

Lead sponsor

Leberstiftungs-GmbH Deutschland

Industry

Registry information

Official study title

German SLD-Registry Characterization of Patients With Steatotic Liver Disease (SLD) in Germany - Phase 1 (Observation of the Natural Course)

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Jan 25, 2021
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed