Effects of Quercetin on Blood Sugar and Blood Vessel Function in Type 2 Diabetes.
NCT ID: NCT01839344
Last Updated: 2015-03-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
19 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2015-03-31
Brief Summary
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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.
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.
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Detailed Description
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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).
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
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Quercetin
Quercetin 250 mg capsules; oral single dose of 2000 mg
Group Type
EXPERIMENTAL
Quercetin
Intervention Type
DIETARY_SUPPLEMENT
Quercetin 250 mg capsules; oral single dose of 2000 mg
Acarbose
Acarbose 100 mg tablet; oral single dose of 100 mg
Group Type
ACTIVE_COMPARATOR
Acarbose
Intervention Type
DRUG
Acarbose 100 mg tablet; oral single dose of 100 mg
Placebo
An oral single dose of a solid, colored empty capsule.
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
An oral single dose of a solid, colored empty capsule.
Interventions
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Quercetin
Quercetin 250 mg capsules; oral single dose of 2000 mg
Intervention Type
DIETARY_SUPPLEMENT
Acarbose
Acarbose 100 mg tablet; oral single dose of 100 mg
Intervention Type
DRUG
placebo
An oral single dose of a solid, colored empty capsule.
Intervention Type
DRUG
Other Intervention Names
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Precose
Eligibility Criteria
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Inclusion Criteria
* Adults aged 18-75 years with the International Classification of diseases book 9 (ICD-9) diagnosis of type 2 diabetes (250.XX). As lack of clarity in ICD-9 coding by providers is notorious in type 2 diabetes, we will specify ICD-9 diagnosis 250.XX in order to capture all subtypes of type 2 diabetes (see ICD-9 book for more information on subtypes).
* Patients on a stable dose (consistent dose for one month) of all medications and supplements.
* Hemoglobin A1c (HbA1c) of 6.5-10.5% within the last year. Since quercetin's effect on blood sugar and endothelial function may be related to its anti-oxidant properties, we are interested in looking at is effect on patients with higher levels of oxidative damage associated with higher blood sugars (i.e. elevated HbA1c \> 6.5%), yet we will exclude those with severe hyperglycemia.
* Stable exercise and diet for last 1 month.
* Patients on a stable dose (consistent dose for one month) of all medications and supplements.
* Hemoglobin A1c (HbA1c) of 6.5-10.5% within the last year. Since quercetin's effect on blood sugar and endothelial function may be related to its anti-oxidant properties, we are interested in looking at is effect on patients with higher levels of oxidative damage associated with higher blood sugars (i.e. elevated HbA1c \> 6.5%), yet we will exclude those with severe hyperglycemia.
* Stable exercise and diet for last 1 month.
Exclusion Criteria
* Current use of insulin or Acarbose (due to possible hypoglycemia); insulin exclusion will ensure exclusion of those with type 1 diabetes.
* Current use of quercetin.
* History of myocardial infarction within the last 6 months, angina, ischemic stroke, uncontrolled hypertension with systolic greater than 180 or diastolic greater than 110.
* Clinical or objective finding suggestive of congestive heart failure Class III or IV or shortness of breath with Activities of Daily Living (ADLs).
* Recent (\<14 days) history of infection. During the telephone screening, if patients have had an acute infection in the last 14 days they will be asked if we may recontact them in 3-4 weeks for a second telephone screening to determine qualification (including resolution of their recent infection \> 14 days).
* Stage IV or higher kidney disease (eGFR \< 30).
* Liver disease (defined as AST or ALT \> 2 x high normal (according to lab range)).
* Prior diagnosis of genetic abnormalities of carbohydrate metabolism (e.g. Congenital Sucrase-Isomaltase, Pompe Disease).
* Pregnant or breast feeding.
* Mental illness or other cognitive impairment prohibiting the candidate from making an informed choice (determined at the discretion of the PI in consult with the Research Assistants/Study Coordinator as needed) as assessed throughout telephone screening and informed consent process.
* Hypersensitivity to quercetin or Acarbose; based on past allergic symptoms taken with either drug or drug or supplement.
* Diagnosis of celiac disease/"sprue".
* Contraindications for EndoPAT:
* Participants on anti-platelet medications will be excluded if they have visible bruising (beyond petechiae).
* Participants will be excluded if they are unwilling to fast for 12 hours prior to maltose tolerance test and/or EndoPAT.
* Participants will be excluded if they have taken nitroglycerine, Cialis, or Viagra 12 hrs before test days.
* In order to accommodate the finger probes, participants will be excluded if they are unwilling to clip their fingernails on their index finger short prior to test days. Index finger nail must not extend past their finger on test days.
* Bilateral upper extremity lymphedema.
* Contraindications for Acarbose:
* Current diabetic ketoacidosis.
* Inflammatory bowel disease; colonic ulceration; partial intestinal obstruction, or in patients predisposed to intestinal obstruction; chronic intestinal diseases with marked maldigestion or malabsorption; hernia.
* Cirrhosis
* Renal impairment (serum creatinine \> 2 mg/dL).
* Current use of quercetin.
* History of myocardial infarction within the last 6 months, angina, ischemic stroke, uncontrolled hypertension with systolic greater than 180 or diastolic greater than 110.
* Clinical or objective finding suggestive of congestive heart failure Class III or IV or shortness of breath with Activities of Daily Living (ADLs).
* Recent (\<14 days) history of infection. During the telephone screening, if patients have had an acute infection in the last 14 days they will be asked if we may recontact them in 3-4 weeks for a second telephone screening to determine qualification (including resolution of their recent infection \> 14 days).
* Stage IV or higher kidney disease (eGFR \< 30).
* Liver disease (defined as AST or ALT \> 2 x high normal (according to lab range)).
* Prior diagnosis of genetic abnormalities of carbohydrate metabolism (e.g. Congenital Sucrase-Isomaltase, Pompe Disease).
* Pregnant or breast feeding.
* Mental illness or other cognitive impairment prohibiting the candidate from making an informed choice (determined at the discretion of the PI in consult with the Research Assistants/Study Coordinator as needed) as assessed throughout telephone screening and informed consent process.
* Hypersensitivity to quercetin or Acarbose; based on past allergic symptoms taken with either drug or drug or supplement.
* Diagnosis of celiac disease/"sprue".
* Contraindications for EndoPAT:
* Participants on anti-platelet medications will be excluded if they have visible bruising (beyond petechiae).
* Participants will be excluded if they are unwilling to fast for 12 hours prior to maltose tolerance test and/or EndoPAT.
* Participants will be excluded if they have taken nitroglycerine, Cialis, or Viagra 12 hrs before test days.
* In order to accommodate the finger probes, participants will be excluded if they are unwilling to clip their fingernails on their index finger short prior to test days. Index finger nail must not extend past their finger on test days.
* Bilateral upper extremity lymphedema.
* Contraindications for Acarbose:
* Current diabetic ketoacidosis.
* Inflammatory bowel disease; colonic ulceration; partial intestinal obstruction, or in patients predisposed to intestinal obstruction; chronic intestinal diseases with marked maldigestion or malabsorption; hernia.
* Cirrhosis
* Renal impairment (serum creatinine \> 2 mg/dL).
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Bastyr University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ryan Bradley, ND, MPH
Role: PRINCIPAL_INVESTIGATOR
Bastyr University
Locations
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Bastyr Center for Natural Health
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Ceriello A, Quagliaro L, Piconi L, Assaloni R, Da Ros R, Maier A, Esposito K, Giugliano D. Effect of postprandial hypertriglyceridemia and hyperglycemia on circulating adhesion molecules and oxidative stress generation and the possible role of simvastatin treatment. Diabetes. 2004 Mar;53(3):701-10. doi: 10.2337/diabetes.53.3.701.
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Standl E, Schnell O. Alpha-glucosidase inhibitors 2012 - cardiovascular considerations and trial evaluation. Diab Vasc Dis Res. 2012 Jul;9(3):163-9. doi: 10.1177/1479164112441524. Epub 2012 Apr 16.
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BACKGROUND
Yee HS, Fong NT. A review of the safety and efficacy of acarbose in diabetes mellitus. Pharmacotherapy. 1996 Sep-Oct;16(5):792-805.
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BACKGROUND
Wascher TC, Schmoelzer I, Wiegratz A, Stuehlinger M, Mueller-Wieland D, Kotzka J, Enderle M. Reduction of postchallenge hyperglycaemia prevents acute endothelial dysfunction in subjects with impaired glucose tolerance. Eur J Clin Invest. 2005 Sep;35(9):551-7. doi: 10.1111/j.1365-2362.2005.01550.x.
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BACKGROUND
Hanefeld M, Cagatay M, Petrowitsch T, Neuser D, Petzinna D, Rupp M. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analysis of seven long-term studies. Eur Heart J. 2004 Jan;25(1):10-6. doi: 10.1016/s0195-668x(03)00468-8.
Reference Type
BACKGROUND
Shimabukuro M, Higa N, Chinen I, Yamakawa K, Takasu N. Effects of a single administration of acarbose on postprandial glucose excursion and endothelial dysfunction in type 2 diabetic patients: a randomized crossover study. J Clin Endocrinol Metab. 2006 Mar;91(3):837-42. doi: 10.1210/jc.2005-1566. Epub 2005 Dec 20.
Reference Type
BACKGROUND
Harwood M, Danielewska-Nikiel B, Borzelleca JF, Flamm GW, Williams GM, Lines TC. A critical review of the data related to the safety of quercetin and lack of evidence of in vivo toxicity, including lack of genotoxic/carcinogenic properties. Food Chem Toxicol. 2007 Nov;45(11):2179-205. doi: 10.1016/j.fct.2007.05.015. Epub 2007 Jun 7.
Reference Type
BACKGROUND
Jeong SM, Kang MJ, Choi HN, Kim JH, Kim JI. Quercetin ameliorates hyperglycemia and dyslipidemia and improves antioxidant status in type 2 diabetic db/db mice. Nutr Res Pract. 2012 Jun;6(3):201-7. doi: 10.4162/nrp.2012.6.3.201. Epub 2012 Jun 30.
Reference Type
BACKGROUND
Vessal M, Hemmati M, Vasei M. Antidiabetic effects of quercetin in streptozocin-induced diabetic rats. Comp Biochem Physiol C Toxicol Pharmacol. 2003 Jul;135C(3):357-64. doi: 10.1016/s1532-0456(03)00140-6.
Reference Type
BACKGROUND
Edwards RL, Lyon T, Litwin SE, Rabovsky A, Symons JD, Jalili T. Quercetin reduces blood pressure in hypertensive subjects. J Nutr. 2007 Nov;137(11):2405-11. doi: 10.1093/jn/137.11.2405.
Reference Type
BACKGROUND
Loke WM, Hodgson JM, Proudfoot JM, McKinley AJ, Puddey IB, Croft KD. Pure dietary flavonoids quercetin and (-)-epicatechin augment nitric oxide products and reduce endothelin-1 acutely in healthy men. Am J Clin Nutr. 2008 Oct;88(4):1018-25. doi: 10.1093/ajcn/88.4.1018.
Reference Type
BACKGROUND
Machha A, Achike FI, Mustafa AM, Mustafa MR. Quercetin, a flavonoid antioxidant, modulates endothelium-derived nitric oxide bioavailability in diabetic rat aortas. Nitric Oxide. 2007 Jun;16(4):442-7. doi: 10.1016/j.niox.2007.04.001. Epub 2007 Apr 20.
Reference Type
BACKGROUND
Ajay M, Achike FI, Mustafa AM, Mustafa MR. Effect of quercetin on altered vascular reactivity in aortas isolated from streptozotocin-induced diabetic rats. Diabetes Res Clin Pract. 2006 Jul;73(1):1-7. doi: 10.1016/j.diabres.2005.11.004. Epub 2005 Dec 27.
Reference Type
BACKGROUND
Ajay M, Achike FI, Mustafa AM, Mustafa MR. Direct effects of quercetin on impaired reactivity of spontaneously hypertensive rat aortae: comparative study with ascorbic acid. Clin Exp Pharmacol Physiol. 2006 Apr;33(4):345-50. doi: 10.1111/j.1440-1681.2006.04373.x.
Reference Type
BACKGROUND
Egert S, Bosy-Westphal A, Seiberl J, Kurbitz C, Settler U, Plachta-Danielzik S, Wagner AE, Frank J, Schrezenmeir J, Rimbach G, Wolffram S, Muller MJ. Quercetin reduces systolic blood pressure and plasma oxidised low-density lipoprotein concentrations in overweight subjects with a high-cardiovascular disease risk phenotype: a double-blinded, placebo-controlled cross-over study. Br J Nutr. 2009 Oct;102(7):1065-74. doi: 10.1017/S0007114509359127. Epub 2009 Apr 30.
Reference Type
BACKGROUND
Kim JH, Kang MJ, Choi HN, Jeong SM, Lee YM, Kim JI. Quercetin attenuates fasting and postprandial hyperglycemia in animal models of diabetes mellitus. Nutr Res Pract. 2011 Apr;5(2):107-11. doi: 10.4162/nrp.2011.5.2.107. Epub 2011 Apr 23.
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BACKGROUND
Allison DB, Paultre F, Maggio C, Mezzitis N, Pi-Sunyer FX. The use of areas under curves in diabetes research. Diabetes Care. 1995 Feb;18(2):245-50. doi: 10.2337/diacare.18.2.245.
Reference Type
BACKGROUND
Conquer JA, Maiani G, Azzini E, Raguzzini A, Holub BJ. Supplementation with quercetin markedly increases plasma quercetin concentration without effect on selected risk factors for heart disease in healthy subjects. J Nutr. 1998 Mar;128(3):593-7. doi: 10.1093/jn/128.3.593.
Reference Type
BACKGROUND
Ferry DR, Smith A, Malkhandi J, Fyfe DW, deTakats PG, Anderson D, Baker J, Kerr DJ. Phase I clinical trial of the flavonoid quercetin: pharmacokinetics and evidence for in vivo tyrosine kinase inhibition. Clin Cancer Res. 1996 Apr;2(4):659-68.
Reference Type
BACKGROUND
Harano Y, Sakamoto A, Izumi K, Shimizu Y, Hoshi M. Usefulness of maltose for testing glucose tolerance. Am J Clin Nutr. 1977 Jun;30(6):924-31. doi: 10.1093/ajcn/30.6.924. No abstract available.
Reference Type
BACKGROUND
Hussain SA, Ahmed ZA, Mahwi TO, Aziz TA. Effect of quercetin on postprandial glucose excursion after mono- and disaccharides challenges in normal and diabetic rats. Journal of Diabetes Mellitus. 2012;2(1):82-87. Doi:10.4236/jdm.2012.21013
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BACKGROUND
Hussain SA, Ahmed ZA, Mahwi TO, Aziz TA. Quercetin dampens postprandial hyperglycemia in type 2 diabetic patients challenged with carbohydrates load. International Journal of Diabetes Research. 2012;1(3):32-35.
Reference Type
BACKGROUND
St. Peter JV, Pirner MA, Halstenson CE, Brundage RC, Khan MA. No impact on oral quercetin on plasma glucose in patients with type 2 diabetes. FASEB Journal. 2011;25:meeting abstracts.
Reference Type
BACKGROUND
Acarbose: Drug information (monograph). In: Uptodate.com. Accessed December 22, 2012.
Reference Type
BACKGROUND
Other Identifiers
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13A-1334
Identifier Type: -
Identifier Source: org_study_id
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