NCT04835831Active, 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

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, Open-label, Multicenter, Multicenter Pilot Study

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

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 metabolic inflammation. NAFLD is in fact a continuum of liver abnormalities that progresses from pure steatosis, to Non-Alcoholic Steato-Hepatitis-NASH, then to hepatic fibrosis, cirrhosis and even the appearance of primary liver cancer (hepatocellular carcinoma). Although many drugs are being tested for advanced forms of NAFLD, steatohepatitis (NASH) with fibrosis and post-NAFLD cirrhosis, there are currently no drugs with marketing authorization. Excessive and unbalanced dietary intake, excessive physical inactivity and lack of regular physical activity are major contributors to the development of NAFLD. It is therefore logical that the preventive and curative treatment of NAFLD is based on hygienic and dietary measures. Physical exercise alone in patients with NAFLD has been shown to improve liver steatosis even in the absence of weight loss. Proof of concept of the improvement in hepatic steatosis has been shown to be achieved by physical activity, whether or not associated with dietary management. More recently, APA (Adapted Physical Activity) is thus seen as a new modality of care that will become central to the prevention and treatment of NAFLD. The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasive inflammation and hepatic fibrosis in patients with NAFLD subjected to the application of personalized dietary measures without or with the performance of personalized and reproducible physical activity via the prescription of adapted physical activity. The evaluation will be carried out initially, at the end of the operation and 6 months after the end of the operation in order to look for a persistent effect of the modification in lifestyle.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 115 (actual)
First submitted: 6 Apr 2021
Start date: 15 Sept 2021
Primary completion date: 15 Jun 2022
Lead sponsor: Centre Hospitalier Universitaire de Nice
Diseases: Fatty liver disease (MASLD/MASH)
NCT number: NCT04835831

What you commit to

Study type: Interventional
Participants enrolled: 115
From 15 Sept 2021 to the primary completion date, 15 Jun 2022
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Weight loss ≥ 10% of usual body weight, in the 6 months prior to inclusion

Other illness

Presence of chronic liver disease from causes other than NAFLDs
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).
Type 1 diabetes
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

Lab values

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.

Other

Patient under legal protection
Refusal to participate in the study
Alcohol consumption ≥ 30 g/d for men or ≥ 20 g/d for women
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
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

Who the study is looking for

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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
CHU de Nice Coordinator of this site? Confirm its status	Nice	France	Unknown status
CH de Perpignan Coordinator of this site? Confirm its status	Perpignan	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.