Lifestyle Modification in the Treatment of NAFLD.

Not Applicable

Recruiting

• Conditions: NAFLD
• Interventions: Behavioral: Cognitive behavioral therapy

• Registration Number: NCT05816915
• Lead Sponsor: General University Hospital, Prague

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.

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Study Start: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Professional lifestyle modification counselling (behavioral therapy)	Cognitive behavioral therapy	Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Czechia