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Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.
Full description
Eligible individuals with type 2 diabetes mellitus will be invited for four study visits. During the first and third study visit, rebaudioside A or the placebo will be administered. During the second and fourth study visit, an oral glucose tolerance test (OGTT) will be executed to measure the response of administration of rebaudioside A versus placebo on the glucose homeostasis. The area under the curve blood glucose values during the first two hours of the OGTT will be compared for both conditions.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Subject is unable to
Women of childbearing potential (last menstruation less than 1 year prior to screening) who are pregnant, lactating or planning to become pregnant during the study.
Individuals with other forms of diabetes
Current or previous treatment with any diabetes drug within 3 months prior to screening, except for metformin.
Symptomatic hyperglycemia requiring immediate therapy during screening, in the judgement of the principal investigator.
Evidence of significant diabetic complications.
History of pancreas or beta-cell transplantation.
Presence or history of clinically relevant medical, surgical or psychiatric conditions likely to affect the subject's safety in this trial or that could confound the study assessments or endpoints.
Clinically relevant abnormal physical findings.
Clinically significant abnormalities of vital signs:
Currently active or history of alcohol abuse.
Currently active or history of drug addiction or currently a regular user of drugs including "recreational use" of any illicit drug.
Smoking cigarettes or using nicotine-containing products, during the last 6 months prior to screening, as nicotine inhibits the Transient Receptor Potential 5 (TRPM5) channel.
Individuals for whom a major surgery is planned to occur between screening and the end of the trial.
Previous or current use of concomitant medication, which would confound the study conduct or implicate a risk for safety of the participant, as judged by the investigator(s).
History of relevant drug or food allergies or a history of severe anaphylactic reaction.
History of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
Individuals with hepatitis B and/or hepatitis C virus.
Individuals with Human Immunodeficiency Virus (HIV).
Participation in another clinical trial involving an investigational product within the 3 months preceding screening or 5-halflives of the drug studied, whichever is longer, prior to study supplement administration. Or, participation in any other type of medical research within 3 months preceding screening judged not to be scientifically or medically compatible with this study.
Individuals who have donated or lost more than 500 ml blood or plasma within 3 months prior to screening.
Individuals unable to swallow orally administered medication.
Individuals in which catheter placement is impossible (amputation, no visible veins, ...)
Individuals that cannot speak or understand the Dutch language.
In the opinion of the principal investigator any other factor that could interfere with the subject's ability to provide informed consent or to complete the study with strict compliance to the study protocol, or that could hold safety concerns for the subject or could impact the outcome of the study results.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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