Breakfast Nutrition and Inpatient Glycemia

Not Applicable

Completed

• Conditions: Diabetes, Type 2; Hyperglycemia; Cardiovascular Disease; Diabetes, Type 1
• Interventions: Other: Modified Carbohydrate Breakfast; Other: Control Breakfast

• Registration Number: NCT01805414
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Last Update Submitted: 2015-10-11
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

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Exclusion Criteria

• Intensive care patients
• No intake by mouth (enteral, parenteral, NPO)
• Taking in nutrition supplements (Ensure, etc)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Breakfast	Modified Carbohydrate Breakfast	40-45g carbs (300-350 kcal)
Control Breakfast	Control Breakfast	These patients received the usual hospital breakfast which contained 40-45 g carbs.

Primary Outcome Measures

Name	Time	Method
Relative change in Blood sugar	Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.	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).

Trial Locations

Locations (1)

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States