Non-Alcoholic Fatty Liver Disease (NAFLDSTEATO-APANCT04835831
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
A study testing adapted physical activity + Dietetic advice in people with Non-Alcoholic Fatty Liver Disease (NAFLD, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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 metabolic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease (NAFLD
- What is being tested?
- adapted physical activity + Dietetic advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Sep 2021to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nice
Nice, France, 06000
Ch de Perpignan
Perpignan, France, 66046
About this study
Official title: 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
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.
Read the 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 improve hepatic steatosis. Since 2017, adapted physical activity (APA) has been a medical prescription by the referring physician in France. APA is thus expected to be a new treatment modality that will become central to the prevention and treatment of NAFLD.
The reference examination for the non-invasive quantification of liver steatosis was the Spectro Magnetic Resonance Imaging (MRI) however this technique is expensive and until now reserved for research in highly specialized centers. More recently, the analysis of the MRI signal by a magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) sequence acquired during the performance of a classical MRI scan has been validated as a new, reliable technique that is easier to use routinely than Spectro MRI. However, different technical variants currently not standardized for the quantification of steatosis by PDFF MRI exist. MRI is not widely available and must be performed in a competent and expert center. In contrast, the quantification of steatosis by ultrasound using the classical "Controlled Attenuation Parameter" (CAP®) is available thanks to a FibroScan, which is widely distributed over France. Even if the quantification of steatosis is better by PDFF MRI than by the classical CAP®, the quantification of steatosis by the classical CAP® is well correlated with the hepatic histology.
In addition, several studies have found a decrease in classical CAP® when applying non-drug or drug therapies to lose weight and/or improve insulin resistance in patients with NAFLD. Very recently, Echosens has developed a new technique -the continuous CAP- to improve the reliability of the classical CAP® in the evaluation of steatosis [Audiere et al. ILC 2020]. Continuous CAP® is no longer based on 10 but on 200 measurements of hepatic steatosis. This new measurement technique reduces the variability of the measurement of liver steatosis quantification by 42%.
The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasively 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 an adapted physical activity. The evaluation will be carried out initially, at the end of the APA program and 24 weeks after the end of the APA program in order to look for a persistent effect of the modification in lifestyle.
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD
- Being tested
- adapted physical activity + Dietetic advice
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activity + Dietetic adviceOther
adapted physical activity during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| adapted physical activity + Dietetic advice | Experimental | Not described Receives: Other: adapted physical activity + Dietetic advice |
| Dietetic advice only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous CAP decreased by 10%
evaluate the decrease in hepatic steatosis by continuous CAP®
Measured: evaluated at day 0
Continuous CAP decreased by 10%
evaluate the decrease in hepatic steatosis by continuous CAP®
Measured: evaluated after the 12 weeks
Secondary outcomes (9)
Anthropometric parameters
assessment of weight
Measured: evaluated at day 0
Anthropometric parameters
assessment of weight
Measured: evaluated after the 12 weeks
Muscular performance
assement with 6-minute walk test
Measured: evaluated at day 0
Muscular performance
assement with 6-minute walk test
Measured: evaluated after the 12 weeks
Muscular performance
assement with 6-minute walk test
Measured: evaluated after the 24 weeks
Muscular performance
assement with 6-minute walk test
Measured: evaluated after the 48 weeks
questionnaire: Short Form 36 Health Survey [SF36].
assessment between 0 to 100
Measured: evaluated at day 0
questionnaire: Short Form 36 Health Survey [SF36].
assessment between 0 to 100
Measured: evaluated after the 24 weeks
questionnaire: Short Form 36 Health Survey [SF36].
assessment between 0 to 100
Measured: evaluated after the 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Sep 2021
- Primary completion15 Jun 2022
- Study completion9 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver Disease (NAFLDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolphe ANTY, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835831
- Sponsor's protocol ID
- 20-AOI-04
- Acronym
- STEATO-APA
- Status last verified
- Nov 2025
- First submitted
- 6 Apr 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04835831
- Acronym / sponsor ID
- STEATO-APA / 20-AOI-04
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 9 Jan 2026 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 improve hepatic steatosis. Since 2017, adapted physical activity (APA) has been a medical prescription by the referring physician in France. APA is thus expected to be a new treatment modality that will become central to the prevention and treatment of NAFLD.
The reference examination for the non-invasive quantification of liver steatosis was the Spectro Magnetic Resonance Imaging (MRI) however this technique is expensive and until now reserved for research in highly specialized centers. More recently, the analysis of the MRI signal by a magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) sequence acquired during the performance of a classical MRI scan has been validated as a new, reliable technique that is easier to use routinely than Spectro MRI. However, different technical variants currently not standardized for the quantification of steatosis by PDFF MRI exist. MRI is not widely available and must be performed in a competent and expert center. In contrast, the quantification of steatosis by ultrasound using the classical "Controlled Attenuation Parameter" (CAP®) is available thanks to a FibroScan, which is widely distributed over France. Even if the quantification of steatosis is better by PDFF MRI than by the classical CAP®, the quantification of steatosis by the classical CAP® is well correlated with the hepatic histology.
In addition, several studies have found a decrease in classical CAP® when applying non-drug or drug therapies to lose weight and/or improve insulin resistance in patients with NAFLD. Very recently, Echosens has developed a new technique -the continuous CAP- to improve the reliability of the classical CAP® in the evaluation of steatosis [Audiere et al. ILC 2020]. Continuous CAP® is no longer based on 10 but on 200 measurements of hepatic steatosis. This new measurement technique reduces the variability of the measurement of liver steatosis quantification by 42%.
The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasively 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 an adapted physical activity. The evaluation will be carried out initially, at the end of the APA program and 24 weeks after the end of the APA program in order to look for a persistent effect of the modification in lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adapted physical activity + Dietetic advice | Experimental | Other: adapted physical activity + Dietetic advice |
| Dietetic advice only | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted physical activity + Dietetic adviceadapted physical activity during 24 weeks | Other | adapted physical activity + Dietetic advice |
Primary outcome
Continuous CAP decreased by 10%
Time frame: evaluated at day 0
evaluate the decrease in hepatic steatosis by continuous CAP®
Continuous CAP decreased by 10%
Time frame: evaluated after the 12 weeks
evaluate the decrease in hepatic steatosis by continuous CAP®
9 secondary outcomes
Anthropometric parameters
Time frame: evaluated at day 0
Anthropometric parameters
Time frame: evaluated after the 12 weeks
Muscular performance
Time frame: evaluated at day 0
Muscular performance
Time frame: evaluated after the 12 weeks
Muscular performance
Time frame: evaluated after the 24 weeks
Muscular performance
Time frame: evaluated after the 48 weeks
questionnaire: Short Form 36 Health Survey [SF36].
Time frame: evaluated at day 0
questionnaire: Short Form 36 Health Survey [SF36].
Time frame: evaluated after the 24 weeks
questionnaire: Short Form 36 Health Survey [SF36].
Time frame: evaluated after the 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolphe ANTY principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity + Dietetic advice in people with Non-Alcoholic Fatty Liver Disease (NAFLD, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous CAP decreased by 10% (time frame: evaluated at day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.