German SLD-Registry (Deutsches SLD-Register)

Recruiting

• Conditions: Steatotic Liver Disease

• Registration Number: NCT04721665
• Lead Sponsor: Leberstiftungs-GmbH Deutschland

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)

Study Timeline

• Study First Submitted: 2020-11-30
• Study Start: 2020-12-01
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2036-11-30
• Study Completion: 2036-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.)
Progression of liver fibrosis	through study completion, an average of 1 year	Fibrosis stage is measured by elastography (elastometry kPa value).
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)

Trial Locations

Locations (14)

MVZ Viszeralmedizin GmbH; 🇩🇪 Köln, Germany

Infektiologisches Zentrum Steglitz; 🇩🇪 Berlin, Germany

Leber- und Studienzentrum Checkpoint; 🇩🇪 Berlin, Germany

MVZ für Gastroenterologie am Bayerischen Platz; 🇩🇪 Berlin, Germany

Gastroenterologische Studiengesellschaft Herne; 🇩🇪 Herne, Germany

Leberstudienzentrum Kiel; 🇩🇪 Kiel, Germany

Praxis Ludwig und Dikopoulos; 🇩🇪 Dornstadt, Germany

Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer; 🇩🇪 Berlin, Germany

MVZ Dres. Eisenbach,Simon, Schwarz GbR; 🇩🇪 Leverkusen, Germany

Fachinternistische Schwerpunktpraxis; 🇩🇪 Hamburg, Germany

Eugastro GmbH; 🇩🇪 Leipzig, Germany

Praxis Dr. med. Kerstin Stein; 🇩🇪 Magdeburg, Germany

CIM GmbH; 🇩🇪 Münster, Germany

St. Josefs-Hospital Medizinische Klinik II; 🇩🇪 Wiesbaden, Germany