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Lifestyle Modification in the Treatment of NAFLD.

Primary Purpose

NAFLD

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
General University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring NAFLD, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Professional lifestyle modification counselling (behavioral therapy)

standard care

Arm Description

Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.

Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists.

Outcomes

Primary Outcome Measures

The effect of CBT on liver fat content
The effect of CBT on liver fat content measured by MRS (percentual change from baseline).
The effect of CBT on inflammatory parameters
The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).
The effect of CBT on liver fibrosis
The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
September 11, 2023
Sponsor
General University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05816915
Brief Title
Lifestyle Modification in the Treatment of NAFLD.
Official Title
Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
Keywords
NAFLD, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Professional lifestyle modification counselling (behavioral therapy)
Arm Type
Experimental
Arm Description
Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
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 Outcome Measure Information:
Title
The effect of CBT on liver fat content
Description
The effect of CBT on liver fat content measured by MRS (percentual change from baseline).
Time Frame
12 months
Title
The effect of CBT on inflammatory parameters
Description
The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).
Time Frame
12 months
Title
The effect of CBT on liver fibrosis
Description
The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radan Bruha, Prof.
Phone
+420224962506
Email
bruha@cesnet.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Vaclav Smid, MD
Phone
+420224962506
Email
vaclav.smid@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radan Bruha, Prof.
Organizational Affiliation
General University Hospital in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radan Bruha, Prof.
Phone
00420224962506
Email
bruha@cesnet.cz
First Name & Middle Initial & Last Name & Degree
Vaclav Smid, Dr.
Phone
00420224962467
Email
vaclav.smid.@vfn.cz

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymized laboratory results.
Citations:
PubMed Identifier
21876630
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.
Results Reference
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PubMed Identifier
35147302
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.
Results Reference
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PubMed Identifier
35176096
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.
Results Reference
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Lifestyle Modification in the Treatment of NAFLD.

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