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The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD/NASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.
Non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation of a metabolic syndrome, is a leading cause of chronic liver disease worldwide. NAFLD is associated with type 2 diabetes, obesity and genetic factors. Despite intensive effort and numerous trials, as of today there is no approved treatment for NAFLD. Weight reduction is recommended, but no long-term control study assessing the evolution of NAFLD/NASH (non-alcoholic steatohepatitis) during lifestyle modification is available.
The main objective of presented project is to compare the progression of NAFLD/NASH in patients with metabolic syndrome randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up. The investigators hypothesize that professionally tailored life-style counselling in patient with metabolic syndrome and NAFLD will improve liver fat content and other non-invasive parameters of liver disease, and factors (including gut microbiota) affecting progression/regression of NAFLD will be identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Professional lifestyle modification counselling (behavioral therapy) | Experimental | Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB. |
|
| standard care | No Intervention | Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | Subjects will receive professional lifestyle intervention conducted by STOB organization. Using CBT and the so-called third wave of CBT, especially mindfulness, the patients will be guided by certified experts to increase motivation and to change eating and exercise habits, which will be mapped before and after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of CBT on liver fat content | The effect of CBT on liver fat content measured by MRS (percentual change from baseline). | 12 months |
| The effect of CBT on inflammatory parameters | The effect of CBT on inflammatory biochemical parameters (percentual change from baseline). | 12 months |
| The effect of CBT on liver fibrosis | The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radan Bruha, Prof. | Contact | +420224962506 | bruha@cesnet.cz | |
| Vaclav Smid, MD | Contact | +420224962506 | vaclav.smid@vfn.cz |
| Name | Affiliation | Role |
|---|---|---|
| Radan Bruha, Prof. | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Recruiting | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21876630 | Background | Zelber-Sagi S, Ratziu V, Oren R. Nutrition and physical activity in NAFLD: an overview of the epidemiological evidence. World J Gastroenterol. 2011 Aug 7;17(29):3377-89. doi: 10.3748/wjg.v17.i29.3377. | |
| 35147302 | Background | Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11. |
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Anonymized laboratory results.
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Patients with NAFLD and metabolic syndrome will be randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up.
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| 35176096 | Background | Fernandez T, Vinuela M, Vidal C, Barrera F. Lifestyle changes in patients with non-alcoholic fatty liver disease: A systematic review and meta-analysis. PLoS One. 2022 Feb 17;17(2):e0263931. doi: 10.1371/journal.pone.0263931. eCollection 2022. |