Viewing Study NCT01805414



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Study NCT ID: NCT01805414
Status: COMPLETED
Last Update Posted: 2015-10-14
First Post: 2013-02-28

Brief Title: Breakfast Nutrition and Inpatient Glycemia
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None