Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of Quercetin in Type 2 Diabetes: Impact on Glucose Tolerance and Postprandial Endothelial Function.
The purpose of this study is to measure the effect of quercetin on glucose tolerance and
postprandial endothelial function in comparison to placebo and Acarbose in participants with
Type 2 Diabetes.
Primary Hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a
100g maltose tolerance test (MTT) will result in a decrease in postprandial blood glucose at
60 minutes compared to placebo. Acarbose (100mg oral), a pharmaceutical alpha-glucosidase
inhibitor, will serve as a positive control.
Secondary Hypothesis: We hypothesize that administration of quercetin (2g oral) will reduce
the Area Under the Glucose Curve (AUC) for the 2 hours following a 100g MTT compared to
placebo. AUC is hypothesized to be comparable between quercetin and Acarbose.
Tertiary hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a
100g MTT will result in a smaller reduction in flow mediated dilation (FMD) measured as an
increase in Reactive Hyperemia Index (RHI) at 90 minutes compared to placebo.
This is a phase II, crossover, double-blinded, controlled trial in 20 participants with type
2 diabetes designed to measure the effect of quercetin on glucose tolerance and postprandial
endothelial function in comparison to placebo and Acarbose. Glucose tolerance and insulin
excursion will be measured at 0, 30, 60, and 120 minutes following a 100g maltose tolerance
test (MTT). Each participant will blindly rotate between three single individual doses of
placebo, quercetin (2g oral), and Acarbose (100mg oral) prior to the MTT on 3 separate
occasions. Each participant will serve as their own control and comparison for each of the
interventions.
Fasting and post-MTT endothelial function will be measured by peripheral tonometry (Itamar
EndoPAT (Peripheral Arterial Tone) 2000) and reported as reactive hyperemia index (RHI).
EndoPAT testing will be performed prior to the fasting blood collection and then again at 90
minutes following the MTT, during each clinical research visit.
Exploratory data will also be collected on post-MTT increases in gamma-glutamyltransferase
(GGT).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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