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Clinical Trials/NCT03003507
NCT03003507
Completed
Phase 4

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

Hospital Moinhos de Vento0 sites25 target enrollmentOctober 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Hospital Moinhos de Vento
Enrollment
25
Primary Endpoint
Glycemic Variability
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
April 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magali Kumbier

Nutritionist

Hospital Moinhos de Vento

Eligibility Criteria

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

Outcomes

Primary Outcomes

Glycemic Variability

Time Frame: four days

To evaluate the glycemic oscillation during the use of enteral feedings

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