Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180646
• Other study ID #: b2d2-01
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2019
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.

Description:

Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• 21-55 y of age

• body mass index (BMI) between 30-40 kg/m2

• weight stable for the prior 6 months

• non-smokers

• minimal alcohol consumption (< 2 drinks per day)

• type 2 diabetic (diagnosed = 2 y)

• a fasting glucose level above 120 mg/dL

• HbA1c between 6.5-9.0%

Exclusion Criteria:

• insulin

• ß-blockers

• GLP-1 agonists (e.g. exenatide)

• dipeptidyl peptidase (DPP) inhibitors

• weight loss

• using weight-loss medications

• pregnant or lactating

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• High protein breakfast
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
• High carb breakfast
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	American Egg Board

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-meal Insulin Level (AUC [0-4])	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480
Other	Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480
Primary	Plasma Glucose Level Post-meal (AUC [0-4])	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480
Secondary	Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480