Study Results
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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RECRUITING
5000 participants
OBSERVATIONAL
2020-12-01
2036-11-30
Brief Summary
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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).
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Detailed Description
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* 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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Study Design
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COHORT
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
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 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
18 Years
ALL
No
Sponsors
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Leberstiftungs-GmbH Deutschland
INDUSTRY
Responsible Party
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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
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
Berlin, , Germany
MVZ Viszeralmedizin GmbH
Cologne, , Germany
Praxis Ludwig und Dikopoulos
Dornstadt, , Germany
Fachinternistische Schwerpunktpraxis
Hamburg, , Germany
Gastroenterologische Studiengesellschaft Herne
Herne, , Germany
Leberstudienzentrum Kiel
Kiel, , Germany
Eugastro GmbH
Leipzig, , Germany
MVZ Dres. Eisenbach,Simon, Schwarz GbR
Leverkusen, , Germany
Praxis Dr. med. Kerstin Stein
Magdeburg, , Germany
CIM GmbH
Münster, , Germany
St. Josefs-Hospital Medizinische Klinik II
Wiesbaden, , Germany
Countries
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Central Contacts
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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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Related information on the registry
Other Identifiers
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NAFLD_01
Identifier Type: -
Identifier Source: org_study_id
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