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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| The effect of urso on GGT | The effect of UDCA therapy on GGT activity (ukat/l; change from baseline). | 6 months |
| 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 |
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients with NAFLD
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| Name | Affiliation | Role |
|---|---|---|
| Radan BRUHA, Prof. | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29080341 | Background | 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. | |
| 30099154 | Background | 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. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Blood samples
| 21145828 | Result | 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. |
| 25603326 | Result | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |