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Abstract Details
Standardization of Diet and Exercise in Clinical Trials of NAFLD-NASH: Recommendations From the Liver Forum
J Hepatol. 2020 Apr 27;S0168-8278(20)30274-9 doi: 10.1016/j.jhep.2020.04.030.Online ahead of print.
Oliver Glass1, Claudia Filozof2, Mazen Noureddin3, Mark Berner-Hansen4, Elmer Schabel5, Stephanie O Omokaro6, Jörn M Schattenberg7, Katherine Barradas8, Veronica Miller8, Sven Francque9, Manal F Abdelmalek10, Liver Forum Standard of Care Working Group
Author information
1Division of General Internal Medicine, Duke University, Durham, North Carolina.
2Covance Inc., Princeton, New Jersey.
3Division of Digestive and Liver Diseases Cedars-Sinai Medical Center, Los Angeles, California.
4Digestive Disease Center, Bispebjerg University Hospital of Copenhagen, Denmark.
5Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
6Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
7Metabolic Liver Research Center, Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
8Forum for Collaborative Research, University of California Berkeley School of Public Health, Washington D.C.
9Division of Gastroenterology & Hepatology, Antwerp University & University Hospital, Antwerp, Belgium. Electronic address: sven.francque@uza.be.
10Division of Gastroenterology and Hepatology, Duke University, Durham, North Carolina. Electronic address: manal.abdelmalek@duke.edu.
Abstract
Lifestyle modification is the foundation of treatment recommendations for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by 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 utilized to better characterize and quantify lifestyle variables, which can influence disease activity, alter trial endpoints, and allow comparison 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 1-4 clinical trials.