Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lifestyle management.
- Кому может быть актуально
- Состояния в реестре: Pediatric Non-alcoholic Fatty Liver Disease. Базовые параметры: 8 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent chronic liver disease worldwide, paralleling the obesity pandemic. Secondary to increasing rates of obesity in children and adolescents, the prevalence of NAFLD has more than doubled in the last decades and is now the most common pediatric liver disease. At present, lifestyle modification by dietary intervention and increasing physical activity is the mainstay of treatment for pediatric NAFLD. Several studies have shown that lifestyle intervention and weight loss improve non-invasive markers of NAFLD. To the investigator's knowledge, data on fibrosis regression following lifestyle treatment in children and adolescents were lacking. The investigators therefore performed a prospective cohort study to investigate the impact of residential lifestyle treatment on liver steatosis and fibrosis in obese children and adolescents. As a follow-up, the investigators now aim to compare these findings with a cohort of well-characterized patients undergoing multidisciplinary, yet ambulatory, weight loss treatment. As such, the investigators will compare the outcomes in two prospective patient cohorts in this non-randomized observational study.
Вмешательства
- Поведенческое Lifestyle management
Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.
Первичные конечные точки
- Improvement of liver fibrosis [Срок оценки: 6 months of lifestyle intervention]
Вторичные конечные точки (9)
- Improvement of liver fibrosis [Срок оценки: 12 months of lifestyle intervention]
- Improvement of liver steatosis [Срок оценки: 6 months of lifestyle intervention]
- Improvement of liver steatosis [Срок оценки: 12 months of lifestyle intervention]
- Resolution of liver steatosis [Срок оценки: 6 months of lifestyle intervention]
- Resolution of liver steatosis [Срок оценки: 12 months of lifestyle intervention]
- Resolution of liver fibrosis [Срок оценки: 6 months of lifestyle intervention]
- Resolution of liver fibrosis [Срок оценки: 12 months of lifestyle intervention]
- Improvement in ALT [Срок оценки: 6 months of lifestyle intervention]
- Improvement in ALT [Срок оценки: 12 months of lifestyle intervention]
Критерии участия
Критерии включения
- Enrolled in the lifestyle management program for obesity in one of the participating centres
Критерии исключения
- Syndromic obesity
- Evidence of liver disease of other causes (viral, auto-immune, genetic)
- Average daily alcohol consumption of >20g/day
- Unvalid screening Fibroscan
- Treatment with drugs which can induce liver steatosis or fibrosis (e.g. systemic corticosteroids, methotrexate)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 3 центра
- AZ Jan Palfijn — Ghent
- University Hospital Gent — Ghent
- Zeepreventorium — De Haan
Публикации
- Lefere S, Dupont E, De Guchtenaere A, Van Biervliet S, Vande Velde S, Verhelst X, Devisscher L, Van Vlierberghe H, Geerts A, De Bruyne R. Intensive Lifestyle Management Improves Steatosis and Fibrosis in Pediatric Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2317-2326.e4. doi: 10.1016/j.cgh.2021.11.039. Epub 2021 Dec 4. PMID 34871812
- Nobili V, Vizzutti F, Arena U, Abraldes JG, Marra F, Pietrobattista A, Fruhwirth R, Marcellini M, Pinzani M. Accuracy and reproducibility of transient elastography for the diagnosis of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology. 2008 Aug;48(2):442-8. doi: 10.1002/hep.22376. PMID 18563842
- Ciardullo S, Monti T, Perseghin G. Prevalence of Liver Steatosis and Fibrosis Detected by Transient Elastography in Adolescents in the 2017-2018 National Health and Nutrition Examination Survey. Clin Gastroenterol Hepatol. 2021 Feb;19(2):384-390.e1. doi: 10.1016/j.cgh.2020.06.048. Epub 2020 Jul 3. PMID 32623006
Идентификаторы
NCT: NCT05309863 · BC-05660