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Breakfast Nutrition and Inpatient Glycemia

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Duke University

Status

Completed

Conditions

Hyperglycemia
Diabetes, Type 2
Diabetes, Type 1
Cardiovascular Disease

Treatments

Other: Control Breakfast
Other: Modified Carbohydrate Breakfast

Study type

Interventional

Funder types

Other

Identifiers

NCT01805414
Pro00031605

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria

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

Trial design

237 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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