Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation

Non-Alcoholic Fatty Liver Disease Clinical Trial

— URSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256979
• Other study ID #: GUHPrague
• Status: Recruiting
• Start date: July 2, 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2023
• Source: General University Hospital, Prague
• Contact: Radan BRUHA, Prof.
• Phone: +420224962506
• Email: bruha[@]cesnet.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

Ampuero J, Gallego-Duran R, Romero-Gomez M. Association of NAFLD with subclinical atherosclerosis and coronary-artery disease: meta-analysis. Rev Esp Enferm Dig. 2015 Jan;107(1):10-6. — View Citation

Ratziu V, de Ledinghen V, Oberti F, Mathurin P, Wartelle-Bladou C, Renou C, Sogni P, Maynard M, Larrey D, Serfaty L, Bonnefont-Rousselot D, Bastard JP, Riviere M, Spenard J; FRESGUN. A randomized controlled trial of high-dose ursodesoxycholic acid for non — View Citation

Sanchez-Garcia A, Sahebkar A, Simental-Mendia M, Simental-Mendia LE. Effect of ursodeoxycholic acid on glycemic markers: A systematic review and meta-analysis of clinical trials. Pharmacol Res. 2018 Sep;135:144-149. doi: 10.1016/j.phrs.2018.08.008. Epub 2018 Aug 9. — View Citation

Vitek L. Bile Acids in the Treatment of Cardiometabolic Diseases. Ann Hepatol. 2017 Nov;16(Suppl. 1: s3-105.):s43-s52. doi: 10.5604/01.3001.0010.5496. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of urso on bile acid metabolism	To assess the effect of UDCA therapy on bile acid metabolism measured as percentual change in blood from baseline.	6 months
Primary	The effect of urso on GGT	The effect of UDCA therapy on GGT activity (ukat/l; change from baseline).	6 months
Primary	The effect of urso on liver fat content	The effect of UDCA therapy on liver fat content measured by MR spectroscopy (percentual change from baseline).	6 months
Primary	The effect of urso on cardiovascular parameters - carotid intima media	The effect of UDCA therapy on carotid intima media thickness measured by ultrasound (change in mm from the baseline)	6 months
Primary	The effect of urso on cardiovascular parameters - endothelial dysfunction	The effect of UDCA therapy on endothelial dysfunction measured in percentual change in ENDO-PAT examination.	6 months