Randomized Controlled Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jun 15, 2021; 12(6): 893-907
Published online Jun 15, 2021. doi: 10.4239/wjd.v12.i6.893
Blood glucose response after oral lactulose intake in type 2 diabetic individuals
Thomas R Pieber, Eva Svehlikova, Ines Mursic, Tamara Esterl, Manfred Wargenau, Tina Sartorius, Lioba Pauly, Susann Schwejda-Guettes, Annalena Neumann, Valentin Faerber, John Friedrich Stover, Barbara Gaigg, Angelika Kuchinka-Koch
Thomas R Pieber, Eva Svehlikova, Ines Mursic, Tamara Esterl, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz 8036, Austria
Manfred Wargenau, Department of Statistic, M.A.R.C.O. GmbH & Co. KG, Institute for Clinical Research and Statistics, Düsseldorf 40211, Germany
Tina Sartorius, Department of Nutritional CRO, BioTeSys GmbH, Esslingen 73728, Germany
Lioba Pauly, Susann Schwejda-Guettes, Department of Medical & Clinical Affairs, Market Access & Education Business Unit Enteral Nutrition, Bad Homburg 61352, Germany
Annalena Neumann, Valentin Faerber, Department of Medical, Clinical & Regulatory Affairs, Business Unit Parenteral Nutrition, Keto-Analogues and Standard I.V. Fluids, Fresenius Kabi Deutschland GmbH, Bad Homburg 61352, Germany
John Friedrich Stover, Department of Consultancy, Stover-Solutions, Zurich 8006, Switzerland
Barbara Gaigg, Angelika Kuchinka-Koch, Market Unit Lactulose, Fresenius Kabi Austria GmbH, Linz 4020, Austria
Author contributions: Pieber TR, Svehlikova E, Mursic I, and Esterl T performed the study, data collection and interpretation; Stover JF, Pauly L, Schwejda-Guettes S, Kuchinka-Koch A, and Gaigg B designed and supervised the study; Wargenau M planned and performed the statistical analysis of the data and interpreted the results; Sartorius T, Neumann A, and Faerber V wrote the manuscript; all authors reviewed, edited, and approved the manuscript for submission.
Supported by Fresenius Kabi Deutschland GmbH, Germany.
Institutional review board statement: This study protocol was reviewed and approved by the Independent Ethics Committee of the Medical University of Graz, Austria.
Clinical trial registration statement: This study was registered in the European Union Drug Regulating Authorities Clinical Trials Database, No. 2018-002359-14.
Informed consent statement: All study participants provided written informed consent prior to enrollment.
Conflict-of-interest statement: The study was sponsored by Fresenius Kabi Deutschland GmbH, Germany. The sponsor’s representatives contributed to the study design and the selection of outcome measures before study start but had no role in study execution or data collection, or data analyses. All other authors declare no potential conflicts of interest related to this paper.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to that statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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/
Corresponding author: Valentin Faerber, PhD, Director, Department of Medical, Clinical & Regulatory Affairs, Business Unit Parenteral Nutrition, Keto-Analogues and Standard I. V. Fluids, Fresenius Kabi Deutschland GmbH, Else-Kroener-Straße 1, Bad Homburg 61352, Germany. valentin.faerber@fresenius-kabi.com
Received: December 3, 2020
Peer-review started: December 3, 2020
First decision: March 14, 2021
Revised: April 7, 2021
Accepted: April 22, 2021
Article in press: April 22, 2021
Published online: June 15, 2021
Processing time: 183 Days and 2.6 Hours
Core Tip

Core Tip: Individuals with diabetes are at risk of developing constipation, which can be symptomatically treated with lactulose. The question arose whether carbohydrate impurities in crystal and liquid lactulose formulations would increase blood glucose levels in individuals with diabetes. This study demonstrates that, at the recommended maintenance dosage of 20 g and at a higher dosage of 30 g lactulose, the blood glucose baseline-corrected area under the curve from 0 to 180 min levels in mildly constipated, non-insulin dependent subjects with type 2 diabetes mellitus are not affected.