German SLD-Registry (Deutsches SLD-Register)

May 26, 2026 updated by: Leberstiftungs-GmbH Deutschland

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

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).

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

1681

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Infektiologisches Zentrum Steglitz
      • Berlin, Germany
        • Leber- und Studienzentrum Checkpoint
      • Berlin, Germany
        • MVZ für Gastroenterologie am Bayerischen Platz
      • Berlin, Germany
        • Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
      • Cologne, Germany
        • MVZ Viszeralmedizin GmbH
      • Dornstadt, Germany
        • Praxis Ludwig und Dikopoulos
      • Hamburg, Germany
        • Fachinternistische Schwerpunktpraxis
      • Herne, Germany
        • Gastroenterologische Studiengesellschaft Herne
      • Kiel, Germany
        • Leberstudienzentrum Kiel
      • Leipzig, Germany
        • EUGASTRO GmbH
      • Leverkusen, Germany
        • MVZ Dres. Eisenbach,Simon, Schwarz GbR
      • Magdeburg, Germany
        • Praxis Dr. med. Kerstin Stein
      • Münster, Germany
        • CIM GmbH
      • Wiesbaden, Germany
        • St. Josefs-Hospital Medizinische Klinik II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The number of patients to be enrolled with SLD is limited to 10,000.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SLD patients
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of liver fibrosis
Time Frame: through study completion, an average of 1 year
Fibrosis stage is measured by elastography (elastometry kPa value).
through study completion, an average of 1 year
Cardiovascular events
Time Frame: through study completion, an average of 1 year
The onset of the clinical outcome cardiovascular events (yes/no)
through study completion, an average of 1 year
Tumor diseases
Time Frame: through study completion, an average of 1 year
The onset of the clinical outcome tumor diseases (yes/no)
through study completion, an average of 1 year
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.)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leberstiftungs-GmbH Deutschland

Investigators

  • Principal Investigator: Stefan Zeuzem, Prof. Dr., Johann Wolfgang Goethe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

April 16, 2026

Study Completion (Actual)

April 16, 2026

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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