Epidemiological evaluation of different biological markers for the classification of non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatohepatitis (NASH) in obese participants with or without Type 2 diabetes

• Conditions: E66; E11; K76.0; Obesity; Type 2 diabetes mellitus; Fatty (change of) liver, not elsewhere classified

• Registration Number: DRKS00017516
• Lead Sponsor: CRS Clinical Research Services Mannheim GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-24
• Results First Posted: 2022-02-21
• Study Completion: 2023-07-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

BMI >28 kg/m2, non-diabetic or Diabetes mellitus type 2

Exclusion Criteria

Pregnant or nursing women
Active implantable medical devices (eg Pacemaker)
Ascites
History of Hepatitis B or C
Positive alcohol or drug test
Only applicable to non-diabetic participants: systemic corticoid treatment
Only applicable to non-diabetic participants: Diabetes mellitus, maltosemalabsorption,
acute gastrointestinal disease, or gastrointestinal resection

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate different markers and scores<br>for the detection of NAFLD and NASH <br>- Steatosis [controlled attenuation parameter (CAP)], fibrosis [elasticity (E)] (single measurement with the FibroScan)<br>- AST to ALT ratio (AAR) (single blood sample)<br>- BARD score (calculated)<br>- Fatty liver index (FLI) (calculated)<br>- NAFDL fibrosis score (NFS) (calculated)

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes:<br>- Laboratory, genomic, metabolomic and<br>proteomic markers (single blood sample)<br>- RNA, micro-RNA, other epigenetic<br>factors (single blood sample)