German NAFLD-Registry (Deutsches NAFLD-Register)

Study Overview
=================
Brief Summary
-----------------
Characterization of patients with non-alcoholic fatty liver disease (NAFLD) The German NAFLD-Registry (Deutsches NAFLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland. The German NAFLD-Registry is financially supported by Gilead Sciences 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 NAFLD) 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)

Official Title
-----------------
German NAFLD-Registry Characterization of Patients With Non-alcoholic Fatty Liver Disease (NAFLD) in Germany - Phase 1 (Observation of the Natural Course)

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed NAFLD based on the following criteria: typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional) Evaluation of NAFLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography Evaluation of metabolic syndrome alcohol consumption <20 g/day (women) and <30 g/day (men) 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) relevant alcoholic liver disease [alcohol consumption >20 g/day (women), >30 g/day (men)] malignant disease with a life expectancy <12 months participation in clinical interventional/pivotal studies inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD patients<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

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