German SLD-Registry (Deutsches SLD-Register)

NCT ID: NCT04721665

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2036-11-30

Brief Summary

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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

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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)

Conditions

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Steatotic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SLD patients

No intervention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leberstiftungs-GmbH Deutschland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Zeuzem, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital

Locations

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Infektiologisches Zentrum Steglitz

Berlin, , Germany

Site Status RECRUITING

Leber- und Studienzentrum Checkpoint

Berlin, , Germany

Site Status RECRUITING

MVZ für Gastroenterologie am Bayerischen Platz

Berlin, , Germany

Site Status RECRUITING

Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer

Berlin, , Germany

Site Status RECRUITING

MVZ Viszeralmedizin GmbH

Cologne, , Germany

Site Status RECRUITING

Praxis Ludwig und Dikopoulos

Dornstadt, , Germany

Site Status RECRUITING

Fachinternistische Schwerpunktpraxis

Hamburg, , Germany

Site Status RECRUITING

Gastroenterologische Studiengesellschaft Herne

Herne, , Germany

Site Status RECRUITING

Leberstudienzentrum Kiel

Kiel, , Germany

Site Status RECRUITING

Eugastro GmbH

Leipzig, , Germany

Site Status RECRUITING

MVZ Dres. Eisenbach,Simon, Schwarz GbR

Leverkusen, , Germany

Site Status RECRUITING

Praxis Dr. med. Kerstin Stein

Magdeburg, , Germany

Site Status RECRUITING

CIM GmbH

Münster, , Germany

Site Status RECRUITING

St. Josefs-Hospital Medizinische Klinik II

Wiesbaden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Yvonne Serfert, Dr.

Role: CONTACT

+49511532 ext. 6968

Facility Contacts

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Gordon Weinberg, Dr.

Role: primary

Renate Heyne, Dr.

Role: primary

Wolf P Hofmann, Prof. Dr.

Role: primary

Jeannette Schwenzer, Dr.

Role: primary

Anna Schmidt, Dr. med.

Role: primary

Nektarios Dikopoulos, Prof. Dr.

Role: primary

Matthias Kahl, Dr.

Role: primary

Manfred von der Ohe, PD Dr.

Role: primary

Holger Hinrichsen, PD Dr.

Role: primary

Ingolf Schiefke, Prof. Dr.

Role: primary

Karl-Georg Simon, Dr.

Role: primary

Kerstin Stein, Dr.

Role: primary

Stefan Christensen, PD Dr.

Role: primary

Christoph Sarrazin, Prof. Dr.

Role: primary

Related Links

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https://www.deutsches-nafld-register.de/

Related information on the registry

Other Identifiers

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NAFLD_01

Identifier Type: -

Identifier Source: org_study_id

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