NCT01839344

Effects of Quercetin on Blood Sugar and Blood Vessel Function in Type 2 Diabetes.

Evaluation of Quercetin in Type 2 Diabetes: Impact on Glucose Tolerance and Postprandial Endothelial Function.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Bastyr University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Quercetin	Quercetin 250 mg capsules; oral single dose of 2000 mg
DRUG	Acarbose	Acarbose 100 mg tablet; oral single dose of 100 mg
DRUG	placebo	An oral single dose of a solid, colored empty capsule.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-03-01
• Completion: 2015-03-01
• First posted: 2013-04-24
• Last updated: 2015-03-18

Locations

1 site across 1 country: United States