Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

Study Overview
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Brief Summary
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Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day. The aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).

Official Title
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Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: Low Carbohydrate Breakfast
* Behavioral: Guidelines Breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed Type 2 Diabetes (>6 months) Exclusion Criteria: Exogenous Insulin A1c > 9% Cardiovascular, liver, or renal other disease Breakfast and meal skippers

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Breakfast<br>Breakfast composition containing <10% carbohydrate, 75% fat, 15% protein Matched calories | Behavioral: Low Carbohydrate Breakfast<br>* A low carbohydrate breakfast containing <10% carbohydrate,  75% fat, and 15% protein. Matched for calories to the active comparator arm.<br>Behavioral: Guidelines Breakfast<br>* A low fat breakfast containing  55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.<br>* Other names: Low-fat Breakfast;|
| Active Comparator: Guidelines Breakfast<br>Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories | Behavioral: Low Carbohydrate Breakfast<br>* A low carbohydrate breakfast containing <10% carbohydrate,  75% fat, and 15% protein. Matched for calories to the active comparator arm.<br>Behavioral: Guidelines Breakfast<br>* A low fat breakfast containing  55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.<br>* Other names: Low-fat Breakfast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the glucose curve (continuous glucose monitor) |  | 24 hour (one day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blod Glucose (continuous glucose monitor) |  | 24 hours (one day) |