Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments dietary fiber-enriched cereal, conventional cereal
Sponsor Seoul National University Hospital
Start date December 2013
End date June 2014
Trial size 15 participants
Trial identifier NCT01997281, 0620132990, H-1307-133-508

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.) one serving (40g) of steamed egg is added for dinner and breakfast
dietary fiber-enriched cereal
provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.) one serving of steamed egg is added for dinner and breakfast
(Other)
conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.) one serving (40g) of steamed egg is added for dinner and breakfast
conventional cereal
provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.) one serving (40g) of steamed egg is added for dinner and breakfast

Primary Outcomes

Measure
Area under the curve (AUC) of plasma total GLP-1 levels after intake of the study meal
time frame: 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
time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of plasma glucose levels after intake of the study meal
time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of plasma insulin levels after intake of the study meal
time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of plasma glucagon levels after intake of the study meal
time frame: 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
time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of plasma total GIP levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of plasma glucose levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of plasma insulin levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of plasma glucagon levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of serum free fatty acid levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of plasma total GLP-1 levels after lunch
time frame: every 30 minutes from noon to 4 p.m. on the second day

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

Official title The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.