Registry for patients with steatotic liver disease in Germany

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

This study is collecting health information from people with steatotic liver disease in Germany to better understand the condition and how it affects their lives.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leberstiftungs-GmbH Deutschland (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 14 sites (Berlin and 13 other locations)
• Trial ID: NCT04721665 on ClinicalTrials.gov

What this trial studies

The German SLD-Registry aims to characterize patients diagnosed with steatotic liver disease (SLD) by collecting comprehensive data on their physical health, comorbidities, laboratory values, and lifestyle factors. This observational study will document various parameters such as age, weight, liver diagnostics, and health-related quality of life using standardized questionnaires. The registry is supported by the German Liver Foundation and aims to enhance understanding of SLD and its associated factors.

Who should consider this trial

Good fit: Ideal candidates for this registry are individuals diagnosed with steatotic liver disease who can provide informed consent.

Not a fit: Patients with other hepatologic diseases or those receiving long-term hepatotoxic medications may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could improve the management and treatment strategies for patients with steatotic liver disease.

How similar studies have performed: Other registries focusing on liver diseases have shown success in improving patient outcomes and understanding disease progression.

Eligibility criteria

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

Where this trial is running

Berlin and 13 other locations

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

Study contacts

• Principal investigator: Stefan Zeuzem, Prof. Dr. — Johann Wolfgang Goethe University Hospital
• Study coordinator: Yvonne Serfert, Dr.

Conditions Steatotic Liver Disease