NCT05256979

Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation

Clinical Observation of the Effect of Ursodeoxycholic Acid on Parameters Affecting Liver, Metabolic and Cardiovascular Morbidity and Mortality - Pilot Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with NAFLD indicated for ursodeoxycholic acid treatment ("by SPC: cholestatic hepatitis") will be offered an observational study. Examinations will be performed before the treatment and after 6month period. Laboratory parameters, non-invasive indices, liver elastography, cardiovascular parameters and liver MR spectroscopy will be performed.

Detailed description

Patients with NAFLD newly indicated for ursodeoxycholic acid treatment will be offered an observational study. Clinical examinations, blood sampling, ultrasound examinations of the liver and liver elastography will be performed. Non-invasive indices evaluating liver fibrosis and steatosis based on common anthropometric and laboratory parameters (FLI, NAFLD fibrosis score, BARD score, APRI, FIB-4) will also be evaluated. The examinations will be repeated after 6 months of treatment (all as part of regular routine check-ups performed in patients with NAFLD). Before and after the follow-up, patients will be offered examinations as part of cardiovascular disease (ultrasound examination of the carotid artery and endothelial dysfunction) and examinations for quantification of hepatic steatosis by MR spectroscopy. Statistical processing: individual parameters will be evaluated before the start of monitoring and after 6-month monitoring. A difference of p≤0.05 will be considered a statistically significant change.

Conditions

• Non-Alcoholic Fatty Liver Disease

Timeline

• Start date: 2022-07-02
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-02-25
• Last updated: 2025-03-17

Locations

1 site across 1 country: Czechia