NCT03003507

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

December 22, 2016

Last Update Submit

December 27, 2016

Conditions

Critical Illness

Keywords

HyperglycemiaFructoseDiabetes mellitusEnteral NutritionGlycemic Variability

Outcome Measures

Primary Outcomes (1)

  • Glycemic Variability

    To evaluate the glycemic oscillation during the use of enteral feedings

    four days

Study Arms (2)

Diet 1

ACTIVE COMPARATOR

Low-carbohydrate Enteral Formula With Fructose

Dietary Supplement: Enteral Formula With Fructose

Diet 2

ACTIVE COMPARATOR

Low-carbohydrate Enteral Formula Without Fructose

Dietary Supplement: Enteral Formula Without Fructose

Interventions

Enteral Formula With FructoseDIETARY_SUPPLEMENT

Low-carbohydrate Enteral Formula With Fructose

Diet 1
Enteral Formula Without FructoseDIETARY_SUPPLEMENT

Low-carbohydrate Enteral Formula Without Fructose

Diet 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical IllnessHyperglycemiaDiabetes Mellitus

Interventions

Fructose

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritionist

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

October 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2013

Last Updated

December 28, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share