NAFLD
Conditions
Keywords
NAFLD, Cognitive behavioral therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive behavioral therapy
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.
Sponsors
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals with NAFLD and metabolic syndrome
Exclusion criteria
* Etiology of liver disease other than NAFLD. * Presence of malignant disease. * Uncontrolled cardiovascular disease * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of CBT on liver fat content | 12 months | The effect of CBT on liver fat content measured by MRS (percentual change from baseline). |
| The effect of CBT on inflammatory parameters | 12 months | The effect of CBT on inflammatory biochemical parameters (percentual change from baseline). |
| The effect of CBT on liver fibrosis | 12 months | The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline). |
Countries
Czechia
Contacts
CONTACTRadan Bruha, Prof.
CONTACTVaclav Smid, MD
PRINCIPAL_INVESTIGATORRadan Bruha, Prof.
General University Hospital, Prague
Outcome results
None listed