Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, incretin hormone, glucose level, GLP-1, GIP, premeal protein
Brief summary
The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones \[glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)\] in healthy subjects and those with type 2 diabetes.
Detailed description
Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.
Interventions
DIETARY_SUPPLEMENTpremeal protein-enriched bar intake
Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.
OTHERbreakfast follows by protein bar
Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18.5\ 35 kg/m2 * Healthy volunteer: * never diagnosed by diabetes and * fasting plasma glucose \<=100mg/dl and HbA1c \<6.0% * participants with diabetes * diagnosed by diabetes * if treated by diet, HbA1c 6.0\ 9.0% * if treated by metformin or SU, HbA1c 6.0\ 10.0% * if treated by DPP4 inhibitor HbA1c 6.0\ 9.0%
Exclusion criteria
* Those who diagnosed by Type 1 diabetes * History of DKA * History of insulin therapy * Allergy to wheat, flour, nuts, milk * Pregnancy/lactation * AST or ALT \>2.5 times of upper normal reference range * eGFR \<30 mL/min/1.73m2 * Hb \<10g/dl * History of GI surgery (except hemorrhoidectomy, appendectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma glucose level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve (AUC) of plasma glucose level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
Secondary
| Measure | Time frame |
|---|---|
| plasma GIP level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve of plasma GIP level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| plasma insulin level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve of plasma insulin level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| plasma total/active GLP-1 level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve of plasma C-peptide level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| plasma glucagon level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve of plasma glucagon level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| plasma C-peptide level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
| Area under the curve of plasma total/active GLP-1 level after breakfast | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min |
Countries
South Korea
Outcome results
None listed