Status:
ACTIVE_NOT_RECRUITING
Interest of APA in Fatty Liver Disease Evaluation of Efficacy and Adherence to an Adapted Physical Activity (APA) Program in Patients With Metabolic Fatty Liver Disease
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Non-Alcoholic Fatty Liver Disease (NAFLD
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Non-Alcoholic Fatty liver Disease (NAFLD) is a Public Health problem. NAFLD affects nearly 25% of the world's population. NAFLD includes hepatic complications related to insulin resistance and metabol...
Detailed Description
Non-Alcoholic Fatty Liver Disease (NAFLD) affects nearly 25% of the world's population and can lead to cirrhosis and hepatocellular carcinoma . Exercise alone in patients with NAFLD has been shown to ...
Eligibility Criteria
Inclusion
- Patient aged 18 and over
- Affiliated with social security
- Signature of informed consent
- Diagnosis of NAFLD characterized by the presence of ultrasound steatosis, with a diagnosis made by a physician after a clinical and paraclinical examination as is usually done in routine care and having eliminated another cause of chronic liver disease.
- Effective contraception system for women of childbearing age, a urine pregnancy test will be offered to these women as part of the assessment of the screening visit.
Exclusion
- Patient under legal protection
- Refusal to participate in the study
- Alcohol consumption ≥ 30 g/d for men or ≥ 20 g/d for women
- Presence of chronic liver disease from causes other than NAFLDs
- Inability to obtain 10 valid measurements when performing a FibroScan liver elasticity measurement or continuous CAP® steatosis assessment during initial evaluation.
- FibroScan ≥ 20 kPa at initial assessment
- Presence or history of advanced chronic liver disease (cirrhosis) decompensated (Child A6, B or C).
- Known history of a complication related to portal hypertension (including digestive haemorrhage related to portal hypertension, ascites or pleural effusion of cirrhotic cirrhosis, port-pulmonary hypertension).
- Notion of type 2 diabetes unbalanced with an HbA1c ≥ 9%, less than 3 months (measurement of HbA1c is not required before signing the consent form).
- Platelets \< 150000/mm3, within the previous 6 months.
- Type 1 diabetes
- Weight loss ≥ 10% of usual body weight, in the 6 months prior to inclusion
- Introduction or dose modification of a GLP1 or orlistat agonist treatment \< 1 year
- Practice of regular and/or intense physical activity, weekly (more than 3 hours per week)
- Patients with solid organ or bone marrow transplants
- Patient participating in another study evaluating a therapy to improve non-alcoholic fatty liver disease (NAFLD)
- Contraindication to carrying out APA:
- Absolute contraindication criteria:
- Any unstable pathology affecting a vital organ in particular cardiovascular or pulmonary. Unstable means any situation in which the absence of urgent therapeutic intervention could lead to the death of the patient.
- o Contraindication to physical activity Unstable acute coronary syndrome Decompensated heart failure Severe, uncontrolled ventricular rhythm disturbances Presence of an intracardiac thrombus with high embolic risk Presence of a medium to large pericardial effusion Recent history (\<6 months) of thrombophlebitis with or without pulmonary embolism Severe and/or symptomatic left ventricular ejection obstruction Any progressive inflammatory and/or infectious disease Severe pulmonary arterial hypertension
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2026
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04835831
Start Date
September 15 2021
End Date
January 9 2026
Last Update
December 3 2025
Active Locations (2)
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1
CHU de Nice
Nice, France, France, 06000
2
Ch de Perpignan
Perpignan, France, France, 66046