E66 E11 K76.0
Conditions
Interventions
Group 1: Single examination (blood sample for laboratory Parameters and genetic markers, elastography of the liver with FibroScan, measurement of waist- and hipcircumference)
in non-diabetic participants oral glucose-tolerance test
Sponsors
CRS Clinical Research Services Mannheim GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: BMI >28 kg/m2, non-diabetic or Diabetes mellitus type 2
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate different markers and scores for the detection of NAFLD and NASH - Steatosis [controlled attenuation parameter (CAP)], fibrosis [elasticity (E)] (single measurement with the FibroScan) - AST to ALT ratio (AAR) (single blood sample) - BARD score (calculated) - Fatty liver index (FLI) (calculated) - NAFDL fibrosis score (NFS) (calculated) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - Laboratory, genomic, metabolomic and proteomic markers (single blood sample) - RNA, micro-RNA, other epigenetic factors (single blood sample) | — |
Countries
Germany
Contacts
Public ContactArmin Schultz
CRS Clinical Research Services Mannheim GmbH
Outcome results
None listed