Print page Print page
Switch language
Bispebjerg Hospital - a part of Copenhagen University Hospital

Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum

Research output: Contribution to journalReviewpeer-review

  1. Cirrhosis Is Associated with Avascular Necrosis, but Not Osteoarthritis: a Danish Population-Based Study

    Research output: Contribution to journalConference abstract in journalpeer-review

  2. Glucocorticosteroids in acute alcoholic hepatitis: the evidence of a beneficial effect is getting even weaker

    Research output: Contribution to journalJournal articlepeer-review

  • Liver Forum Standard of Care Working Group
View graph of relations

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.

Original languageEnglish
JournalJournal of Hepatology
Issue number3
Pages (from-to)680-693
Number of pages14
Publication statusPublished - Sep 2020

ID: 61702979