Breakfast Nutrition and Inpatient Glycemia

NCT01805414 | Completed

• 1 other identifier: Pro00031605
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes, Type 1; Diabetes, Type 2; Cardiovascular Disease; Hyperglycemia

Keywords

inpatient diabetes; inpatient diabetes nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention Breakfast

EXPERIMENTAL

40-45g carbs (300-350 kcal)

Other: Modified Carbohydrate Breakfast

Control Breakfast

ACTIVE COMPARATOR

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

Other: Control Breakfast

Interventions

Modified Carbohydrate Breakfast OTHER

Also known as: Breakfast with 40-45g carbohydrates

Intervention Breakfast

Control Breakfast OTHER

Also known as: 40-45g carbs

Control Breakfast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Hyperglycemia

Interventions

Breakfast; Carbohydrates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lillian F Lien, MD

  Duke Medical Center

  PRINCIPAL INVESTIGATOR

• Kathryn J Evans, NP

  Duke Medical Center

  STUDY DIRECTOR

• Mark N Feinglos, MD

  Duke Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 6, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 14, 2015

Record last verified: 2013-02

Locations

US (1)