Status:
COMPLETED
Investigating the Use of Quercetin on Glucose Absorption in Obesity, and Obesity With Type 2 Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
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 absorptio...
Eligibility Criteria
Inclusion
- 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 (such that fasting blood sugar \<200mg/dl or HbA1C \< 8.5), 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, known gastroparesis, 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. Severity of diabetes and biological duration of action of the drug will determine when to initiate this hold (from 3 to 7 days prior to OGTT). 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 If the fasting blood glucose in the morning exceeds 300 mg/dl, the subject will be withdrawn from the study and appropriate therapy resumed.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 illness. Healthy, normal weight subjects (BMI \<25) will also be recruited as control subjects for the sampling study without querecetin. 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; pregnancy (a urine pregnancy test will be performed on all women with reproductive age before each part of the study); lactation; 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.
Exclusion
Key Trial Info
Start Date :
April 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00065676
Start Date
April 30 2010
End Date
August 6 2021
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892