Breakfast Nutrition and Inpatient Glycemia

NCT01805414 — Not applicable, Completed, 237 participants, Duke University

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The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control

Registry	NCT01805414
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none
Enrollment	237 (Actual)
Sponsor	Duke University (Other)
Conditions	Diabetes, Type 1, Diabetes, Type 2, Cardiovascular Disease, Hyperglycemia
Interventions	Modified Carbohydrate Breakfast, Control Breakfast (Other)
Dates	start 2012-09-01, primary completion 2012-11-01, completion 2012-11-01, first posted 2013-03-06, last updated 2015-10-14
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention Breakfast	Experimental	Other: Modified Carbohydrate Breakfast	40-45g carbs (300-350 kcal)
Control Breakfast	Active comparator	Other: Control Breakfast	These patients received the usual hospital breakfast which contained 40-45 g carbs.

Modified Carbohydrate Breakfast (Other), also known as Breakfast with 40-45g carbohydrates
Control Breakfast (Other), also known as 40-45g carbs

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Duke Medical Center	Durham, North Carolina	United States

+Investigators

Lillian F Lien, MD, Principal investigator, Duke Medical Center
Kathryn J Evans, NP, Study director, Duke Medical Center
Mark N Feinglos, MD, Study chair, Duke Medical Center