Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065676
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2003-07-30
Brief Title:
Investigating the Use of Quercetin on Glucose Absorption in Obesity and Obesity With Type 2 Diabetes
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Inhibition of Intestinal Glucose Absorption by the Bioflavonoid Quercetin in the Obese and in Obese Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2024-03-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 glucose will reduce plasma glucose concentrations during a 6 hour oral glucose tolerance test with 3 to 6 grams of 3-O-methyl glucose 3OMG in non-diabetic obese subjects and in obese type 2 diabetic subjects The glucose dose may be varied from 0 to 100 grams to better understand the competition between 3OMG and glucose 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 greater than or equal to 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 Additionally to determine the optimal 3OMG dose we will study the absorption of glucose and 3OMG without quercetin in 12 non-diabetic obese subjects and 12 lean subjects to serve as controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DK-0256 | None | None | None |