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Clinical Trial NCT05816915 for NAFLD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Lifestyle Modification in the Treatment of NAFLD. 100 Microbiome Lifestyle
Clinical Trial NCT05816915 is an interventional study for NAFLD that is recruiting. It started on 30 August 2023 with plans to enroll 100 participants. Led by General University Hospital, Prague, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 25 September 2024.
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/NAS...Show More
Official Title
Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease
Conditions
NAFLDPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- NU23-01-00288
NCT ID Number
Start Date (Actual)
2023-08-30
Last Update Posted
2024-09-25
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
NAFLD
Cognitive behavioral therapy
Cognitive behavioral therapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalProfessional lifestyle modification counselling (behavioral therapy) Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB. | Cognitive behavioral therapy 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. |
No Interventionstandard care 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. | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The effect of CBT on liver fat content | The effect of CBT on liver fat content measured by MRS (percentual change from baseline). | 12 months |
The effect of CBT on inflammatory parameters | The effect of CBT on inflammatory biochemical parameters (percentual change from baseline). | 12 months |
The effect of CBT on liver fibrosis | The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline). | 12 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Individuals with NAFLD and metabolic syndrome
- Etiology of liver disease other than NAFLD.
- Presence of malignant disease.
- Uncontrolled cardiovascular disease
- Pregnancy.
General University Hospital, PragueStudy Responsible Party
Radan Bruha, Principal Investigator, Head of 4th Internal clinic, General University Hospital, Prague
Study Central Contact
Contact: Radan Bruha, Prof., +420224962506, [email protected]
Contact: Vaclav Smid, MD, +420224962506, [email protected]
1 Study Locations in 1 Countries
General University Hospital, Prague, 12808, Czechia
Radan Bruha, Prof., Contact, 00420224962506, [email protected]
Vaclav Smid, Dr., Contact, 00420224962467, [email protected]
Recruiting