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

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enteral Formula With Fructose
Enteral Formula Without Fructose
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Hyperglycemia, Fructose, Diabetes mellitus, Enteral Nutrition, Glycemic Variability

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Diet 1

    Diet 2

    Arm Description

    Low-carbohydrate Enteral Formula With Fructose

    Low-carbohydrate Enteral Formula Without Fructose

    Outcomes

    Primary Outcome Measures

    Glycemic Variability
    To evaluate the glycemic oscillation during the use of enteral feedings

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2016
    Last Updated
    December 27, 2016
    Sponsor
    Hospital Moinhos de Vento
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03003507
    Brief Title
    Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients
    Official Title
    Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Moinhos de Vento

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness
    Keywords
    Hyperglycemia, Fructose, Diabetes mellitus, Enteral Nutrition, Glycemic Variability

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diet 1
    Arm Type
    Active Comparator
    Arm Description
    Low-carbohydrate Enteral Formula With Fructose
    Arm Title
    Diet 2
    Arm Type
    Active Comparator
    Arm Description
    Low-carbohydrate Enteral Formula Without Fructose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Enteral Formula With Fructose
    Intervention Description
    Low-carbohydrate Enteral Formula With Fructose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Enteral Formula Without Fructose
    Intervention Description
    Low-carbohydrate Enteral Formula Without Fructose
    Primary Outcome Measure Information:
    Title
    Glycemic Variability
    Description
    To evaluate the glycemic oscillation during the use of enteral feedings
    Time Frame
    four days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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