Breakfast Nutrition and Inpatient Glycemia

Cardiovascular Disease Clinical Trial

Official title:

The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805414
• Other study ID #: Pro00031605
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: October 11, 2015
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 1
• Diabetes, Type 2
• Hyperglycemia

Intervention

Other:
• Modified Carbohydrate Breakfast

• Control Breakfast

Locations

Country	Name	City	State
United States	Duke Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No