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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
General University Hospital
Prague, Czechia
RECRUITINGThe effect of CBT on liver fat content
The effect of CBT on liver fat content measured by MRS (percentual change from baseline).
Time frame: 12 months
The effect of CBT on inflammatory parameters
The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).
Time frame: 12 months
The effect of CBT on liver fibrosis
The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).
Time frame: 12 months
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