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NCT Number: NCT05816915

Lifestyle Modification in the Treatment of NAFLD.

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. The effect of CBT on inflammatory parameters

    Time frame: 12 months

    The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Radan Bruha, Prof.

CONTACT

[email protected]

+420224962506

Vaclav Smid, MD

CONTACT

[email protected]

+420224962506

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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