NCT04835831Fut, nem toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 115 (tényleges)
- Első benyújtás
- 2021. ápr. 6.
- Kezdés
- 2021. szept. 15.
- Elsődleges befejezés
- 2022. jún. 15.
- Fő szponzor
- Centre Hospitalier Universitaire de Nice
- Betegségek
- Zsírmáj (MASLD/MASH)
- NCT-szám
- NCT04835831
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 115
- 2021. szept. 15. és az elsődleges befejezés (2022. jún. 15.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Weight loss ≥ 10% of usual body weight, in the 6 months prior to inclusion
Más betegség
- 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
Laborértékek
- 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.
Egyéb
- 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
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU de Nice | Nice | Franciaország | Ismeretlen állapot |
| CH de Perpignan | Perpignan | Franciaország | Ismeretlen állapot |
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