Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835831
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2021-04-06
Brief 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
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEATO-APA
Brief Summary:
Non-Alcoholic Fatty liver Disease NAFLD is a Public Health problem NAFLD affects nearly 25 of the worlds 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 worlds 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None