German SLD-Registry (Deutsches SLD-Register)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04721665

Enrollment

1681

Registered

2021-01-25

Start date

2020-12-01

Completion date

2026-04-16

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steatotic Liver Disease

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 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).

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 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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Progression of liver fibrosis	through study completion, an average of 1 year	Fibrosis stage is measured by elastography (elastometry kPa value).
Activity of metabolic dysfunction-associated steatohepatitis (MASH)	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	through study completion, an average of 1 year	The onset of the clinical outcome cardiovascular events (yes/no)
Tumor diseases	through study completion, an average of 1 year	The onset of the clinical outcome tumor diseases (yes/no)

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORStefan Zeuzem, Prof. Dr.

Johann Wolfgang Goethe University Hospital

Outcome results