Clinical trial NCT05816915: Lifestyle Modification in the Treatment of NAFLD.
Official title: Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Keywords: NAFLD
Cognitive behavioral therapy
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The effect of CBT on liver fat content
timeFrame: 12 months
measure: The effect of CBT on inflammatory parameters
timeFrame: 12 months
measure: The effect of CBT on liver fibrosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: General University Hospital, Prague
name: Radan Bruha, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zelber-Sagi S, Ratziu V, Oren R. Nutrition and physical activity in NAFLD: an overview of the epidemiological evidence. World J Gastroenterol. 2011 Aug 7;17(29):3377-89. doi: 10.3748/wjg.v17.i29.3377.
citation: Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.
citation: Fernandez T, Vinuela M, Vidal C, Barrera F. Lifestyle changes in patients with non-alcoholic fatty liver disease: A systematic review and meta-analysis. PLoS One. 2022 Feb 17;17(2):e0263931. doi: 10.1371/journal.pone.0263931. eCollection 2022.