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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003507
Enrollment
25
Registered
2016-12-28
Start date
2009-10-31
Completion date
2013-04-30
Last updated
2016-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Hyperglycemia, Fructose, Diabetes mellitus, Enteral Nutrition, Glycemic Variability

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.

Interventions

DIETARY_SUPPLEMENTEnteral Formula With Fructose

Low-carbohydrate Enteral Formula With Fructose

DIETARY_SUPPLEMENTEnteral Formula Without Fructose

Low-carbohydrate Enteral Formula Without Fructose

Sponsors

Hospital Moinhos de Vento
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic Variabilityfour daysTo evaluate the glycemic oscillation during the use of enteral feedings

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026