Breakfast Nutrition and Inpatient Glycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Diabetes, Type 1 Diabetes, Type 2 Cardiovascular Disease Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Intervention Breakfast

40-45g carbs (300-350 kcal)

Group Type EXPERIMENTAL

Modified Carbohydrate Breakfast

Intervention Type OTHER

Control Breakfast

These patients received the usual hospital breakfast which contained 40-45 g carbs.

Group Type ACTIVE_COMPARATOR

Control Breakfast

Intervention Type OTHER

Interventions

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Modified Carbohydrate Breakfast

Intervention Type OTHER

Control Breakfast

Intervention Type OTHER

Other Intervention Names

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Breakfast with 40-45g carbohydrates 40-45g carbs

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