Breakfast Nutrition and Inpatient Glycemia

Study Overview
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Brief Summary
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A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital no concentrated sweets (NCS) breakfast meals with more balanced meals. The study team hypothesized that a balanced breakfast would improve pre-lunch BG values. This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD). Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All patients on Ward A (with and without diabetes) were given the intervention breakfast for the first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS meals). After 4 weeks, the standard and intervention wards were switched. Data were collected only on patients with diabetes who were able to consume meals.

Official Title
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The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control

Conditions
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Diabetes, Type 1, Diabetes, Type 2, Cardiovascular Disease, Hyperglycemia

Intervention / Treatment
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* Other: Modified Carbohydrate Breakfast
* Other: Control Breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with cardiovascular disease who were admitted to 2 pre-specified wards at Duke Medical Center during the study period Diagnosis of diabetes (type 1 or 2) or newly identified hyperglycemia (blood glucose of >200 on 2 separate occasions) Able to consume food by mouth Exclusion Criteria: Intensive care patients No intake by mouth (enteral, parenteral, NPO) Taking in nutrition supplements (Ensure, etc)

Ages Eligible for Study
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Minimum Age: 18 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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Breakfast<br>40-45g carbs (300-350 kcal) | Other: Modified Carbohydrate Breakfast<br> <br> * Other names: Breakfast with 40-45g carbohydrates;|
| Active Comparator: Control Breakfast<br>These patients received the usual hospital breakfast which contained 40-45 g carbs. | Other: Control Breakfast<br> <br> * Other names: 40-45g carbs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in Blood sugar | The primary outcome will be the relative change between the pre-breakfast and pre-lunch blood glucose levels after the intervention breakfast. The hypothesis is that the intervention breakfast will lead to lower pre-lunch blood sugars. Blood glucoses will be measured before breakfast and lunch on eligible patients. This will occur every day for the duration of the study (8 weeks). The relative change between the pre-breakfast and pre-lunch blood glucose will be assessed by BG2 (pre-lunch) minus BG1 (pre-breakfast). | Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inpatient diabetes, inpatient diabetes nutrition