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OpenTrials
Completed

NCT Number: NCT03003507

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

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.

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Key information

Conditions

Critical Illness Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Formula With Fructose

Dietary Supplement

Low-carbohydrate Enteral Formula With Fructose

Enteral Formula Without Fructose

Dietary Supplement

Low-carbohydrate Enteral Formula Without Fructose

Primary outcomes

  1. Glycemic Variability

    Time frame: four days

    To evaluate the glycemic oscillation during the use of enteral feedings

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Dec 28, 2016
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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