Evidence map›Paper›PMID 36057030›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2022

Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial.

Caroline Simoens, Koenraad Philippaert, Caroline Wuyts, Séverine Goscinny, Els Van Hoeck, Joris Van Loco, Jaak Billen, Jan de Hoon, Els Ampe, Roman Vangoitsenhoven and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03510624 (Investigation of the Acute Effect of Rebaudioside A on the Glucose Excursion During an Oral Glucose Tolerance Test in 30 Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03510624 phase1completednot on this map

Investigation of the Acute Effect of Rebaudioside A on the Glucose Excursion During an Oral Glucose Tolerance Test in 30 Patients With Type 2 Diabetes Mellitus (AREBAG)

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2018 to 2021Enrolled30ConditionsType 2 Diabetes MellitusArmsRebaudioside A, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Caroline SimoensLaboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0001-8446-052X
Koenraad PhilippaertLaboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-5861-2275
Caroline WuytsLaboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-9526-1590
Séverine GoscinnyChemical and Physical Health Risks, Sciensano, Elsene, Belgium.ORCID http://orcid.org/0000-0002-2248-9930
Els Van HoeckChemical and Physical Health Risks, Sciensano, Elsene, Belgium.ORCID http://orcid.org/0000-0002-1172-2338
Joris Van LocoChemical and Physical Health Risks, Sciensano, Elsene, Belgium.ORCID http://orcid.org/0000-0001-8439-3371
Jaak BillenDepartment of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-4852-4340
Jan de HoonCenter for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-5215-9836
Els AmpeCenter for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-4675-8824
Roman VangoitsenhovenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-3523-669X
Ann MertensClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-1649-4311
Rudi VennekensLaboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-2564-5150
Bart Van der SchuerenClinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium. bart.vanderschueren@kuleuven.be.ORCID http://orcid.org/0000-0003-4754-784X
KU Leuven · BEVIB-KU Leuven Center for Brain & Disease Research · BESciensano (Belgium) · BE

Funding

Fonds Wetenschappelijk Onderzoek G0C2420NFonds Wetenschappelijk Onderzoek GOE0217NKU Leuven C14/17/091
6 · The paper itself

Abstract

BACKGROUND AND

objectivesRebaudioside A, a steviol glycoside, is deglycosylated by intestinal microflora prior to the absorption of steviol and conjugation to steviol glucuronide. While glucose-lowering properties are observed for rebaudioside A in mice, they have been attributed to the metabolites steviol and steviol glucuronide. We aimed to characterize the pharmacokinetic and pharmacodynamic properties of rebaudioside A and its metabolites in patients with early-onset type 2 diabetes mellitus (T2DM).

methodsThis randomized, placebo-controlled, open-label, two-way crossover trial was performed in subjects with T2DM on metformin or no therapy at the University Hospitals Leuven, Belgium. Following oral rebaudioside A (3 g), plasma concentrations of rebaudioside A, steviol and steviol glucuronide were determined. The effect on glucose homeostasis was examined by an oral glucose tolerance test (OGTT) performed 19 h following rebaudioside A administration, i.e. the presumed time of maximal steviol and steviol glucuronide concentrations. The primary pharmacodynamic endpoint was the difference in area under the blood glucose concentration-time curve during the first 2 h of the OGTT (AUC

resultsIn total, 30 subjects [63.5 (57.8-69.0) years of age, 86.7% male] completed the trial. Rebaudioside A was detected as early as 1 h after administration in nearly all subjects. As expected, steviol and steviol glucuronide reached their maximal concentrations at 19.5 h following rebaudioside A administration. Rebaudioside A did not lower the AUC

conclusionRebaudioside A is readily absorbed after oral administration and metabolized to steviol and steviol glucuronide. However, no effect on glucose nor insulin or C-peptide excursion was observed during the OGTT at the time of maximal metabolite concentrations. Thus, no antidiabetic properties of rebaudioside A could be observed in patients with T2DM after single oral use. CLINICAL

trial registrationRegistered on ClinicalTrials.gov (NCT03510624).

Indexed as

Diabetes Mellitus, Type 2Diterpenes, KauraneAgedBlood GlucoseC-PeptideCross-Over StudiesFemaleGlucoseGlucuronidesHomeostasisHumansMaleMiddle AgedBlood GlucoseC-PeptideDiterpenes, KauraneGlucoseGlucuronidesrebaudioside Asteviol

Identifiers

PMID36057030
PMCPMC9440320
OpenAlexW4294379477

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.