Status:
COMPLETED
Effects of Quercetin on Blood Sugar and Blood Vessel Function in Type 2 Diabetes.
Lead Sponsor:
Bastyr University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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. ...
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 fu...
Eligibility Criteria
Inclusion
- 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.
- Labs (HbA1c, aspartate aminotransferase (AST), Alanine transaminase (ALT), Glomerular filtration rate (GFR), and creatinine) measured within the last year and meet inclusion/exclusion criteria or we will run them.
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01839344
Start Date
May 1 2013
End Date
March 1 2015
Last Update
March 18 2015
Active Locations (1)
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1
Bastyr Center for Natural Health
Seattle, Washington, United States, 98103