Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation

Active, not recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease

• Registration Number: NCT05256979
• Lead Sponsor: General University Hospital, Prague

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Study Start: 2022-07-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Individuals with NAFLD with ALT elevation and cholestatic features who are indicated for standard treatment with ursodeoxycholic acid according to SPC ("Hepatitis of various etiologies with cholestatic syndrome").

Exclusion Criteria

• Previous treatment with ursodeoxycholic acid.
• Diagnosis of cirrhosis at the start of the study.
• Etiology of liver disease other than NAFLD.
• Presence of malignant disease.
• Cardiovascular comorbidity: CHD / CHD on pharmacological therapy, history of myocardial infarction, stroke and coronary / carotid intervention.
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of urso on GGT	6 months	The effect of UDCA therapy on GGT activity (ukat/l; change from baseline).
The effect of urso on liver fat content	6 months	The effect of UDCA therapy on liver fat content measured by MR spectroscopy (percentual change from baseline).
The effect of urso on cardiovascular parameters - carotid intima media	6 months	The effect of UDCA therapy on carotid intima media thickness measured by ultrasound (change in mm from the baseline)
The effect of urso on cardiovascular parameters - endothelial dysfunction	6 months	The effect of UDCA therapy on endothelial dysfunction measured in percentual change in ENDO-PAT examination.

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Czechia