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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003507
• Other study ID #: v4n3n8xw
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2016
• Last updated: December 27, 2016
• Start date: October 2009
• Est. completion date: April 2013

Study information

• Verified date: December 2016
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness

Intervention

Dietary Supplement:
• Enteral Formula With Fructose
Low-carbohydrate Enteral Formula With Fructose
• Enteral Formula Without Fructose
Low-carbohydrate Enteral Formula Without Fructose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Variability	To evaluate the glycemic oscillation during the use of enteral feedings	four days	No