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

Phase 4

Completed

• Conditions: Critical Illness
• Interventions: Dietary Supplement: Enteral Formula With Fructose; Dietary Supplement: Enteral Formula Without Fructose

• Registration Number: NCT03003507
• Lead Sponsor: Hospital Moinhos de Vento

Brief Summary

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.

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 Timeline

• Study Start: 2009-10
• Primary Completion: 2011-04
• Study Completion: 2013-04
• Status Verified: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-27
• Last Update Submitted: 2016-12-27
• Study First Posted: 2016-12-28
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diet 1	Enteral Formula With Fructose	Low-carbohydrate Enteral Formula With Fructose
Diet 2	Enteral Formula Without Fructose	Low-carbohydrate Enteral Formula Without Fructose

Primary Outcome Measures

Name	Time	Method
Glycemic Variability	four days	To evaluate the glycemic oscillation during the use of enteral feedings