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Authors
Simoens, Caroline https://orcid.org/0000-0001-8446-052X
Philippaert, Koenraad https://orcid.org/0000-0002-5861-2275
Wuyts, Caroline https://orcid.org/0000-0002-9526-1590
Goscinny, Séverine https://orcid.org/0000-0002-2248-9930
Van Hoeck, Els https://orcid.org/0000-0002-1172-2338
Van Loco, Joris https://orcid.org/0000-0001-8439-3371
Billen, Jaak https://orcid.org/0000-0003-4852-4340
de Hoon, Jan https://orcid.org/0000-0002-5215-9836
Ampe, Els https://orcid.org/0000-0002-4675-8824
Vangoitsenhoven, Roman https://orcid.org/0000-0003-3523-669X
Mertens, Ann https://orcid.org/0000-0002-1649-4311
Vennekens, Rudi https://orcid.org/0000-0002-2564-5150
Van der Schueren, Bart https://orcid.org/0000-0003-4754-784X
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03510624 at ClinicalTrials.govDocuments that mention this clinical trial
Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial
https://doi.org/10.1007/s13318-022-00792-7
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Funding
Funding for this research was provided by:
KU Leuven (C14/17/091)
Fonds Wetenschappelijk Onderzoek (G0C2420N)
Fonds Wetenschappelijk Onderzoek (GOE0217N)
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Article History
Accepted: 31 July 2022
First Online: 3 September 2022
Declarations
:
: The study was funded by a KU Leuven Grant (TRPLe: TRP Research Platform Leuven - C14/17/091) and FWO Vlaanderen (G0C2420N and GOE0217N).
: There is no conflict of interest for any of the authors.
: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: The study was approved by the institutional review board (Ethics Committee Research UZ/KU Leuven, Leuven, Belgium) and the national competent authority (Federal Agency for Medicines and Health Products (FAMPH), Belgium). The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments.
: Informed consent was obtained from all individual participants prior to the initiation of any study-related procedure.
: Not applicable.
: CS, KP, RV and BVdS contributed substantially to the conceptualization of the study. CS, RVG, AM and BVdS recruited subjects, conducted the experiments and collected data. JdH coordinated the clinical team involved in practical assistance for the trial and the manufacturing of the drug. EA manufactured the drug. CS, SG, EVH and JVL analyzed the pharmacokinetic samples. CS, CW and JB analyzed the pharmacodynamic samples. CS and BVdS did the formal analysis. RV provided funding. BVdS supervised the project. CS drafted the manuscript, and RV and BVdS reviewed and edited the manuscript. All authors contributed to the interpretation of the data and critically revised the manuscript.
