The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589028
• Other study ID #: H-1504-103-666
• Status: Completed
• Phase: N/A
• First received: October 26, 2015
• Last updated: November 27, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• premeal 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.

Other:
• breakfast 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma glucose level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Primary	Area under the curve (AUC) of plasma glucose level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	plasma total/active GLP-1 level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	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
Secondary	plasma GIP level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	Area under the curve of plasma GIP level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	plasma insulin level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	Area under the curve of plasma insulin level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	plasma C-peptide level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	Area under the curve of plasma C-peptide level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	plasma glucagon level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary	Area under the curve of plasma glucagon level after breakfast		-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min