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

NCT ID: NCT03003507

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Critical Illness

Keywords

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Hyperglycemia Fructose Diabetes mellitus Enteral Nutrition Glycemic Variability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diet 1

Low-carbohydrate Enteral Formula With Fructose

Group Type ACTIVE_COMPARATOR

Enteral Formula With Fructose

Intervention Type DIETARY_SUPPLEMENT

Low-carbohydrate Enteral Formula With Fructose

Diet 2

Low-carbohydrate Enteral Formula Without Fructose

Group Type ACTIVE_COMPARATOR

Enteral Formula Without Fructose

Intervention Type DIETARY_SUPPLEMENT

Low-carbohydrate Enteral Formula Without Fructose

Interventions

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Enteral Formula With Fructose

Low-carbohydrate Enteral Formula With Fructose

Intervention Type DIETARY_SUPPLEMENT

Enteral Formula Without Fructose

Low-carbohydrate Enteral Formula Without Fructose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Moinhos de Vento

OTHER

Sponsor Role lead

Responsible Party

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Magali Kumbier

Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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v4n3n8xw

Identifier Type: -

Identifier Source: org_study_id