Skip to main content
OpenTrials
Completed

NCT Number: NCT01805414

Breakfast Nutrition and Inpatient Glycemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Modified Carbohydrate Breakfast

Other

Other names: Breakfast with 40-45g carbohydrates

Control breakfast

Other

Other names: 40-45g carbs

Primary outcomes

  1. Relative change in Blood sugar

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2013
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.