Clinical trial NCT02589028: The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones
Official title: The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
incretin hormone
glucose level
GLP-1
GIP
premeal protein
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: plasma glucose level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve (AUC) of plasma glucose level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary outcomes:
measure: plasma total/active GLP-1 level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve of plasma total/active GLP-1 level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: plasma GIP level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve of plasma GIP level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: plasma insulin level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve of plasma insulin level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: plasma C-peptide level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve of plasma C-peptide level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: plasma glucagon level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
measure: Area under the curve of plasma glucagon level after breakfast
timeFrame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine
name: Young Min Cho, MD, PHD
role: STUDY_CHAIR
References: