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Lifestyle Modification in the Treatment of NAFLD.

Lifestyle Modification in the Treatment of NAFLD.

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details
    NAFLD

NCT05816915

General University Hospital, Prague

27 January 2024

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