Clinical trial NCT05256979: Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation
Official title: Clinical Observation of the Effect of Ursodeoxycholic Acid on Parameters Affecting Liver, Metabolic and Cardiovascular Morbidity and Mortality - Pilot Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: NAFLD
Liver steatosis
Liver fibrosis
Ursodeoxycholic acid
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NAFLD

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of urso on GGT
timeFrame: 6 months
measure: The effect of urso on liver fat content
timeFrame: 6 months
measure: The effect of urso on cardiovascular parameters - carotid intima media
timeFrame: 6 months
measure: The effect of urso on cardiovascular parameters - endothelial dysfunction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: The effect of urso on bile acid metabolism
timeFrame: 6 months
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: General University Hospital, Prague
name: Radan BRUHA, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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 nonalcoholic steatohepatitis. J Hepatol. 2011 May;54(5):1011-9. doi: 10.1016/j.jhep.2010.08.030. Epub 2010 Oct 31.
citation: 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.