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

• Conditions: on-Alcoholic Fatty Liver Disease (NAFLD); K76.0; Fatty (change of) liver, not elsewhere classified

• Registration Number: DRKS00023780
• Lead Sponsor: niversitätsklinikum Leipzig Klinik für Gastroenterologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-07
• Study Completion: 2023-03-31
• Results First Posted: 2023-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation 95% limits of agreement between first and second LSM measurement

Secondary Outcome Measures

Name	Time	Method
Estimation of time dependent LSM-difference and variation<br>Estimation 95% limits of agreement for FIB-4, NFS, FAST-score<br>Incidence and prevalence of cardiovascular and hepatic endpoints