The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT01997281
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
- Detailed Description
Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- type 2 diabetes mellitus
- HbA1c 6.5~8.5%
- on life style modification or metformin monotherapy at the time of screening
- on sulfonylurea or insulin therapy at the time of screening
- allergy to wheat, flour, other cereals or nuts
- lactose intolerance
- pregnancy / lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.
- Secondary Outcome Measures
Name Time Method AUC of Plasma Insulin Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day AUC of Plasma Glucagon Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day AUC of Plasma Glucose Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day AUC of Plasma Total GLP-1 Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day AUC of Plasma Total GIP Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day AUC of Plasma Total GIP Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day AUC of Plasma Glucose Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day AUC of Serum Free Fatty Acid Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day AUC of Plasma Glucagon Levels After Intake of the Study Meal every 30 minutes from 8 a.m. to noon on the second day AUC of Plasma Insulin Levels After Lunch every 30 minutes from noon to 4 p.m. on the second day
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of