Breakfast Nutrition and Inpatient Glycemia

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01805414

Collaborator

(none)

237

Enrollment

Location

Arms

Duration (Months)

118.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes, Type 1 Diabetes, Type 2 Cardiovascular Disease Hyperglycemia	Other: Modified Carbohydrate Breakfast Other: Control Breakfast	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

237 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Breakfast 40-45g carbs (300-350 kcal)	Other: Modified Carbohydrate Breakfast Other Names: Breakfast with 40-45g carbohydrates
Active Comparator: Control Breakfast These patients received the usual hospital breakfast which contained 40-45 g carbs.	Other: Control Breakfast Other Names: 40-45g carbs

Arm

Intervention/Treatment

Experimental: Intervention Breakfast

40-45g carbs (300-350 kcal)

Other: Modified Carbohydrate Breakfast

Other Names:

Breakfast with 40-45g carbohydrates

Active Comparator: Control Breakfast

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

Other: Control Breakfast

Other Names:

40-45g carbs

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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