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Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum.
Glass, Oliver; Filozof, Claudia; Noureddin, Mazen; Berner-Hansen, Mark; Schabel, Elmer; Omokaro, Stephanie O; Schattenberg, Jörn M; Barradas, Katherine; Miller, Veronica; Francque, Sven; Abdelmalek, Manal F.
Afiliación
  • Glass O; Division of General Internal Medicine, Duke University, Durham, North Carolina.
  • Filozof C; Covance Inc., Princeton, New Jersey.
  • Noureddin M; Division of Digestive and Liver Diseases Cedars-Sinai Medical Center, Los Angeles, California.
  • Berner-Hansen M; Digestive Disease Center, Bispebjerg University Hospital of Copenhagen, Denmark.
  • Schabel E; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
  • Omokaro SO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Schattenberg JM; Metabolic Liver Research Center, Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
  • Barradas K; Forum for Collaborative Research, University of California Berkeley School of Public Health, Washington D.C.
  • Miller V; Forum for Collaborative Research, University of California Berkeley School of Public Health, Washington D.C.
  • Francque S; Division of Gastroenterology & Hepatology, Antwerp University & University Hospital, Antwerp, Belgium. Electronic address: sven.francque@uza.be.
  • Abdelmalek MF; Division of Gastroenterology and Hepatology, Duke University, Durham, North Carolina. Electronic address: manal.abdelmalek@duke.edu.
J Hepatol ; 73(3): 680-693, 2020 09.
Article en En | MEDLINE | ID: mdl-32353483
Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-classes. This summary by the Liver Forum's Standard of Care Working Group reviews currently available clinical data, identifies the barriers and challenges associated with the standard of care in NAFLD/NASH clinical trials, defines available assessments of lifestyle changes, and proposes approaches to better understand and define the influence of diet and exercise on NASH treatment in the context of different pharmacologic interventions. The ultimate objective is to propose tangible solutions which enable investigators, sponsors, and regulatory authorities to meaningfully interpret clinical trial outcomes and the impact of lifestyle modification on such outcomes as they pertain to phase I-IV clinical trials.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Ejercicio Físico / Terapia por Ejercicio / Enfermedad del Hígado Graso no Alcohólico / Dieta Saludable Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: J Hepatol Asunto de la revista: GASTROENTEROLOGIA Año: 2020 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Ejercicio Físico / Terapia por Ejercicio / Enfermedad del Hígado Graso no Alcohólico / Dieta Saludable Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: J Hepatol Asunto de la revista: GASTROENTEROLOGIA Año: 2020 Tipo del documento: Article