Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- NAFLD
- Sponsor
- General University Hospital, Prague
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The effect of CBT on liver fat content
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Radan Bruha
Head of 4th Internal clinic
General University Hospital, Prague
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The effect of CBT on liver fat content
Time Frame: 12 months
The effect of CBT on liver fat content measured by MRS (percentual change from baseline).
The effect of CBT on inflammatory parameters
Time Frame: 12 months
The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).
The effect of CBT on liver fibrosis
Time Frame: 12 months
The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).