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Clinical Trial Details

Trial ID: L3404
Source ID: NCT03510624
Associated Drug: Rebaudioside A
Title: Acute Effect of Rebaudioside A on Glucose Excursion During an Oral Glucose Tolerance Test in Type 2 Diabetes Mellitus
Acronym: AREBAG
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Rebaudioside A|DRUG: Placebo
Outcome Measures: Primary: Area under the curve (AUC) blood glucose concentrations during an OGTT, Area under the curve blood glucose concentrations during an OGTT, 0 to 2 hours after glucose challenge | Secondary: AUC glucose/insulin/glucagon, AUC glucose/insulin/glucagon, -30 to 0 min of OGTT|AUC glucose/insulin/glucagon, AUC glucose/insulin/glucagon, 0 to 30 min of OGTT|AUC glucose/insulin/glucagon, AUC glucose/insulin/glucagon, 0 to 4 hours of OGTT|Maximal blood glucose, Maximal blood glucose, -30 min to 4 hours of OGTT|Maximal blood glucose excursion, Maximal blood glucose excursion, -30 min to 4 hours of OGTT|Maximal serum insulin, Maximal serum insulin, -30 min to 4 hours of OGTT|Maximal serum glucagon, Maximal serum glucagon, -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, -30 min to 4 hours of OGTT
Sponsor/Collaborators: Sponsor: Universitaire Ziekenhuizen KU Leuven
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-11-09
Completion Date: 2021-04-01
Results First Posted:
Last Update Posted: 2021-04-28
Locations: Centrum Clinical Pharmacology, Leuven, Flanders, 3000, Belgium
URL: https://clinicaltrials.gov/show/NCT03510624