Completed

Balanced vs. Standard Hospital Breakfast Impact on Inpatient Glycemic Control

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Study Aim

This study aims to evaluate how a balanced hospital breakfast, compared to a standard one, impacts blood sugar levels in hospitalized patients, by measuring changes in blood glucose levels before breakfast and lunch over an 8-week period.

What is being tested

Modified Carbohydrate Breakfast

+ Control Breakfast

Other
Who is being recruted

Autoimmune Diseases+8

+ Diabetes Mellitus

+ Endocrine System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorDuke University
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorDuke University
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

237 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersCardiovascular DiseasesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Hyperglycemia

Criteria

3 inclusion criteria required to participate
Able to consume food by mouth

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)

3 exclusion criteria prevent from participating
Intensive care patients

No intake by mouth (enteral, parenteral, NPO)

Taking in nutrition supplements (Ensure, etc)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
40-45g carbs (300-350 kcal)

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Medical Center

Durham, United StatesOpen Duke Medical Center in Google Maps
CompletedOne Study Center