- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04835831
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 (STEATO-APA)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rodolphe ANTY
- Phone Number: 0492034702
- Email: anty.r@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- CHU de Nice
-
Contact:
- Phone Number: 0492034702
-
Principal Investigator:
- Anty Rodolphe
-
Perpignan, France, 66046
- Recruiting
- CH de Perpignan
-
Principal Investigator:
- Remy Jean Andre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: adapted physical activity + Dietetic advice
|
adapted physical activity during 24 weeks
|
No Intervention: Dietetic advice only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous CAP decreased by 10%
Time Frame: evaluated at day 0
|
evaluate the decrease in hepatic steatosis by continuous CAP®
|
evaluated at day 0
|
Continuous CAP decreased by 10%
Time Frame: evaluated after the 12 weeks
|
evaluate the decrease in hepatic steatosis by continuous CAP®
|
evaluated after the 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric parameters
Time Frame: evaluated at day 0
|
assessment of weight
|
evaluated at day 0
|
Anthropometric parameters
Time Frame: evaluated after the 12 weeks
|
assessment of weight
|
evaluated after the 12 weeks
|
Muscular performance
Time Frame: evaluated at day 0
|
assement with 6-minute walk test
|
evaluated at day 0
|
Muscular performance
Time Frame: evaluated after the 12 weeks
|
assement with 6-minute walk test
|
evaluated after the 12 weeks
|
Muscular performance
Time Frame: evaluated after the 24 weeks
|
assement with 6-minute walk test
|
evaluated after the 24 weeks
|
Muscular performance
Time Frame: evaluated after the 48 weeks
|
assement with 6-minute walk test
|
evaluated after the 48 weeks
|
questionnaire: Short Form 36 Health Survey [SF36].
Time Frame: evaluated at day 0
|
assessment between 0 to 100
|
evaluated at day 0
|
questionnaire: Short Form 36 Health Survey [SF36].
Time Frame: evaluated after the 24 weeks
|
assessment between 0 to 100
|
evaluated after the 24 weeks
|
questionnaire: Short Form 36 Health Survey [SF36].
Time Frame: evaluated after the 48 weeks
|
assessment between 0 to 100
|
evaluated after the 48 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rodolphe ANTY, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-AOI-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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