Clinical trial NCT01997281: The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
Official title: The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: dietary fiber
diabetes mellitus
gut hormone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* HbA1c 6.5\~8.5%
* on life style modification or metformin monotherapy at the time of screening

Exclusion Criteria:

* on sulfonylurea or insulin therapy at the time of screening
* allergy to wheat, flour, other cereals or nuts
* lactose intolerance
* pregnancy / lactation

Primary outcomes:
measure: Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
Secondary outcomes:
measure: AUC of Plasma Total GIP Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
measure: AUC of Plasma Glucose Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
measure: AUC of Plasma Insulin Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
measure: AUC of Plasma Glucagon Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
measure: AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal
timeFrame: every 30 minutes from 8 a.m. to noon on the second day
measure: AUC of Plasma Total GIP Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
measure: AUC of Plasma Glucose Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
measure: AUC of Plasma Insulin Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
measure: AUC of Plasma Glucagon Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
measure: AUC of Serum Free Fatty Acid Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
measure: AUC of Plasma Total GLP-1 Levels After Lunch
timeFrame: every 30 minutes from noon to 4 p.m. on the second day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Young Min Cho, MD, PHD
role: STUDY_CHAIR
References:
citation: Kim EK, Oh TJ, Kim LK, Cho YM. Improving Effect of the Acute Administration of Dietary Fiber-Enriched Cereals on Blood Glucose Levels and Gut Hormone Secretion. J Korean Med Sci. 2016 Feb;31(2):222-30. doi: 10.3346/jkms.2016.31.2.222. Epub 2016 Jan 26.