Randomized Controlled Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 7, 2017; 23(1): 141-150
Published online Jan 7, 2017. doi: 10.3748/wjg.v23.i1.141
Sitagliptin in patients with non-alcoholic steatohepatitis: A randomized, placebo-controlled trial
Tisha R Joy, Charles A McKenzie, Rommel G Tirona, Kelly Summers, Shannon Seney, Subrata Chakrabarti, Neel Malhotra, Melanie D Beaton
Tisha R Joy, Department of Medicine, Division of Endocrinology, St. Joseph’s Hospital, Western University, London, Ontario N6A 4V2, Canada
Charles A McKenzie, Department of Medical Biophysics, Western University, London, Ontario N6A 4V2, Canada
Rommel G Tirona, Department of Physiology and Pharmacology, Western University, London, Ontario N6A 4V2, Canada
Kelly Summers, Shannon Seney, Department of Microbiology and Immunology, Western University, London, Ontario N6A 4V2, Canada
Subrata Chakrabarti, Department of Pathology and Laboratory Medicine, Western University, London, Ontario N6A 4V2, Canada
Neel Malhotra, Melanie D Beaton, Department of Medicine, Division of Gastroenterology, London Health Sciences Centre, Western University, London, Ontario N6A 5A5, Canada
Author contributions: Joy TR and Beaton MD contributed equally to this work and designed the research; Joy TR, Tirona RG, Summers K, Seney S, McKenzie CA and Beaton MD performed the research; Joy TR, McKenzie CA, Tirona RG, Summers K, Seney S, Malhotra N and Beaton MD contributed to the interpretation of the results; Joy TR and Beaton MD wrote the manuscript; and Joy TR, McKenzie CA, Tirona RG, Summers K, Seney S, Malhotra N and Beaton MD provided critical revisions of the manuscript.
Supported by the Physicians’ Services Incorporated Foundation 10q2083 (Joy TR and Beaton MD); Academic Medical Organization of Southwestern Ontario, No. F10-002 (Beaton MD); as well as partly funded through academic research funds from the Program of Experimental Medicine (Joy TR); and Department of Medicine Academic Funds (Joy TR) from Western University, London, Ontario, Canada.
Institutional review board statement: This study was reviewed and approved by the Western University Research Ethics Board (REB#17389), London, Ontario, Canada.
Clinical trial registration statement: This study was registered at www.Clinicaltrials.gov. The registration identification number is NCT01260246.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Joy TR has received speakers’ honoraria from Merck, Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Janssen, Astra Zeneca; served as an advisory board member or consultant to Amgen, Sanofi, Novo Nordisk, Merck, and participated in clinical trials with Amgen and Astra Zeneca. Beaton MD has served as an advisory board member or consultant for Abbvie, Allergan and Takeda, and participated in clinical trials with Gilead and Intercept. The remaining authors have no conflict of interest to report.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Melanie D Beaton, Associate Professor, Department of Medicine, Division of Gastroenterology, London Health Sciences Centre, Western University, 339 Windermere Road, London, Ontario N6A 5A5, Canada. melanie.beaton@lhsc.on.ca
Telephone: +1-519-6633344 Fax: +1-519-6633220
Received: September 29, 2016
Peer-review started: September 30, 2016
First decision: December 2, 2016
Revised: December 9, 2016
Accepted: December 21, 2016
Article in press: December 21, 2016
Published online: January 7, 2017
Processing time: 98 Days and 6.3 Hours
Core Tip

Core tip: Presently, there is no approved medical therapy for non-alcoholic steatohepatitis (NASH). In this randomized placebo-controlled trial, the effect of sitagliptin on liver fibrosis in patients with NASH after 24 wk was evaluated. There was no significant improvement with the use of sitagliptin on liver fibrosis, total non-alcoholic fatty liver disease activity score or its individual components. Similarly, there were no significant improvements in liver enzymes, adipocytokines, lipid profile, thrombosis parameters, or adipose distribution. There was a strong correlation between hepatic fat % measured using the MRI IDEAL technique and hepatic steatosis on liver biopsy.