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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: High protein breakfast
* Other: High carb breakfast


Participation Criteria
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Eligibility Criteria
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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 β-blockers GLP-1 agonists (e.g. exenatide) dipeptidyl peptidase (DPP) inhibitors weight loss using weight-loss medications pregnant or lactating

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Carb then High Protein Breakfast<br>A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat). | Other: High protein breakfast<br>* a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)<br>Other: High carb breakfast<br>* a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)<br>|
| Active Comparator: High Protein then High Carb Breakfast<br>A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) | Other: High protein breakfast<br>* a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)<br>Other: High carb breakfast<br>* a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose Level Post-meal (AUC [0-4]) | AUC for 4 hr after breakfast and after lunch | 0-240 and 240-480 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | AUC for 4 hr after breakfast and after lunch | 0-240 and 240-480 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, GIP, second meal phenomena, type 2 diabetes