Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients

Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial

Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Dietary supplement: Enteral Formula With Fructose; Dietary supplement: Enteral Formula Without Fructose

Detailed Description

Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Critical Illness
• Exclusive enteral diet
• Enteral diet with full nutritional value
• Hyperglycemia ≥180 mg / dl

Exclusion Criteria:

• Oral feeding
• NPT (Total or Partial Parenteral Nutrition)
• Patient without indication of use of study diets

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet 1; Low-carbohydrate Enteral Formula With Fructose	Dietary supplement: Enteral Formula With Fructose; Low-carbohydrate Enteral Formula With Fructose
Active Comparator: Diet 2; Low-carbohydrate Enteral Formula Without Fructose	Dietary supplement: Enteral Formula Without Fructose; Low-carbohydrate Enteral Formula Without Fructose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Variability	To evaluate the glycemic oscillation during the use of enteral feedings	four days

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 27, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Fructose; Hyperglycemia; Diabetes mellitus; Enteral Nutrition; Glycemic Variability
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: v4n3n8xw

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO