Prospective evaluation of NAFLD patients with diabetes mellitus type 2 using transient elastography

Prospective evaluation of NAFLD patients with diabetes mellitus type 2 using transient elastography - Prospective NAFLD characterisation of NAFLD patients with diabetes mellitus type 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023780

Enrollment

200

Registered

2020-12-07

Start date

2021-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) K76.0

Interventions

Group 1: One outpatient visit including B-mode ultrasound, transient elastography including CAP, blood draw to calculate FIB-4 and NFS. These data will be compared to already existing retrospective da

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Participation in one of the previous trials of the study group 2) Age > 18 years 3) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Participation in clinical NAFLD/NASH trials evaluating treatment interventions 2) Pregnancy/lactation 3) Planned relevant medical intervention (i.e. bariatric surgery)

Design outcomes

Primary

Measure	Time frame
Estimation "95% limits of agreement" between first and second LSM measurement	—

Secondary

Measure	Time frame
Estimation of time dependent LSM-difference and variation Estimation "95% limits of agreement" for FIB-4, NFS, FAST-score Incidence and prevalence of cardiovascular and hepatic endpoints	—

Countries

Germany

Contacts

Public ContactJohannes Wiegand

Universitätsklinikum Leipzig Klinik für Gastroenterologie

johannes.wiegand@medizin.uni-leipzig.de+493419712330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026