Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Investigating the Use of Quercetin on Glucose Absorption in Obesity, and Obesity With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00065676
First received: July 30, 2003
Last updated: October 10, 2014
Last verified: September 2014
  Purpose

Quercetin is a compound naturally found in various foods. It may have some role in the treatment of obesity and diabetes.

The purpose of this study is to investigate research volunteers with obesity or obesity with type 2 diabetes to determine whether quercetin affects the way glucose is absorbed by the body.

Thirty two participants aged 19 to 65 who are considered to be medically obese or obese with type 2 diabetes will be enrolled in this study. Before the onset of treatment, they will undergo a medical history, physical exam, blood work, and urinalysis. During the study, participants will be given an oral glucose tolerance test three times; during these tests they will receive 1 or 2 grams of quercetin, or placebo. Researchers will collect blood samples and analyze the effect of the treatment on blood glucose.


Condition Intervention Phase
Diabetes Mellitus
Obesity
Procedure: Oral glucose tolerance test
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Inhibition of Intestinal Glucose Absorption by the Bioflavonoid Quercetin in the Obese and in Obese Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Efficacy of quercetin on blunting hyperglycemia [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2003
Estimated Study Completion Date: December 2015
Intervention Details:
    Procedure: Oral glucose tolerance test
    N/A
Detailed Description:

Postprandial hyperglycemia and the resultant hyperinsulinemia contribute to the cardiovascular complications seen in obesity and in type 2 diabetes. Epidemiological studies suggest that slow absorption of carbohydrates dampens glucose and insulin peaks, and reduces cardiovascular morbidity. The polyphenol quercetin is the most abundant flavanoid in plant-derived foods, and is sold as a dietary supplement. In vitro, quercetin is a potent and reversible inhibitor of glucose transport by the intestinal glucose transporter GLUT2. In vivo quercetin inhibits post absorptive glucose peaks in obese, diabetic rats. We hypothesize that quercetin blunts intestinal glucose absorption in humans, and attenuates postprandial hyperglycemia. We propose to test, in a double blind placebo controlled study, whether coadministration of 1 or 2 grams of quercetin with 50 grams of glucose will reduce plasma glucose concentrations during a 6 hour 50g oral glucose tolerance test in non-diabetic obese subjects and in obese type 2 diabetic subjects. 3OMG is a non-metabolizable glucose analogue and is excreted unaltered in urine. 3OMG is not found in food and thus glucose absorption can be studies easily without the problem of a high baseline value. The use of 3OMG will provide a more accurate and true measures of glucose absorption. Study subjects will be 19 - 65 years with a body mass index (Bullet) 30, without complications of diabetes, or on any medication other than oral hypoglycemic agents and aspirin. We will study 16 obese non diabetic subjects and 16 obese type 2 diabetics. Each subject will have 3 oral glucose tolerance tests, and will serve as his or her own control. We will compare the peak plasma glucose concentrations achieved during oral glucose tolerance tests and the area under the curve of plasma glucose to determine whether quercetin inhibits glucose absorption in humans. Such inhibition may partially explain the protective effects of plant derived foods on cardiovascular disease, and enable us to use quercetin or related compounds to dampen intestinal glucose absorption. We will also measure quercetin concentrations in the plasma, in circulating white blood cells and in urine to determine quercetin pharmacokinetics.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Subjects to be recruited for the study will be male and female subjects between the ages of 18 and 65, able to give informed consent, with mild to moderate type 2 diabetes (on treatment with diet alone and/or oral hypoglycemic agents such that fasting blood sugar < 200mg/dl or HbA1C < 8.5; insulin treatment is not allowed), in otherwise good general health, with no other significant illnesses, blood pressure < =160/90 mmHg with or without medication, with no known severe target organ damage. End organ damage includes the following: proliferative retinopathy, serum creatinine > 2, ischemic heart disease, congestive heart failure, peripheral vascular disease and severe peripheral neuropathy. Diabetic subjects must have a BMI greater than or equal to 30. Subjects will be taken off hypoglycemic agents for 3 to 7 days prior to each part of the study. This is to remove a confounding factor that may affect blood glucose concentrations attained during the OGTT, independent of the effect of quercetin. Whether these oral hypoglycemic agents have physiologically significant interaction with quercetin is not known. During the time that the subjects are off oral hypoglycemic agents, they will monitor their fasting blood glucose daily by glucometer. Therefore, for subjects with diabetes, only those subjects who self-monitor blood glucose are eligible for inclusion. If the fasting blood glucose in the morning exceeds 300 mg/dl, the subject will be withdrawn from the study and appropriate therapy resumed. Obese volunteers, with a BMI greater than or equal to 30, must be in good health, with no known. An upper age limit of 65 years was chosen to minimize renal toxicity of quercetin, as GFR declines with age and quercetin might produce mild though reversible renal impairment.

EXCLUSION CRITERIA:

Exclusion criteria will include the following: significant digestive abnormalities such as malabsorption or chronic diarrhea; significant organ malfunction including (but not limited to) liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, hypertension (BP > 160/90), and anemia (hematocrit < 30); other serious or chronic illness; history of serious or chronic illness; any significant complications from diabetes such as kidney damage (renal insufficiency, serum creatinine > 2), eye damage (proliferative retinopathy), severe diabetic neuropathy, coronary artery disease, or symptomatic peripheral vascular disease; smoking; alcohol or drug abuse; smokers; insulin treatment; pregnancy (a urine pregnancy test will be performed on all women with reproductive age before each part of the study); positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results). Diabetic subjects who choose not to self-monitor glucose daily by glucometer will be excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065676

Contacts
Contact: Sebastian J Padayatty, M.D. (301) 496-1069 sebastianp@intra.niddk.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Sebastian J Padayatty, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00065676     History of Changes
Other Study ID Numbers: 030256, 03-DK-0256
Study First Received: July 30, 2003
Last Updated: October 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hyperglycemia
Hyperinsulinemia
OGTT
GLUT2
Post-Prandial
Type 2 Diabetes
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014