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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Rebaudioside A 3g
Empty capsules
Centrum Clinical Pharmacology
Leuven, Flanders, Belgium
Area under the curve (AUC) blood glucose concentrations during an OGTT
Area under the curve blood glucose concentrations during an OGTT
Time frame: 0 to 2 hours after glucose challenge
AUC glucose/insulin/glucagon
AUC glucose/insulin/glucagon
Time frame: -30 to 0 min of OGTT
AUC glucose/insulin/glucagon
AUC glucose/insulin/glucagon
Time frame: 0 to 30 min of OGTT
AUC glucose/insulin/glucagon
AUC glucose/insulin/glucagon
Time frame: 0 to 4 hours of OGTT
Maximal blood glucose
Maximal blood glucose
Time frame: -30 min to 4 hours of OGTT
Maximal blood glucose excursion
Maximal blood glucose excursion
Time frame: -30 min to 4 hours of OGTT
Maximal serum insulin
Maximal serum insulin
Time frame: -30 min to 4 hours of OGTT
Maximal serum glucagon
Maximal serum glucagon
Time frame: -30 min to 4 hours of OGTT
Concentration(t) (C(t))rebaudioside A, steviol and steviol glucuronide
Concentration of rebaudioside A, steviol and steviol glucuronide on different time points
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Time frame: -30 min to 4 hours of OGTT