The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

NCT ID: NCT02337556

Last Updated: 2018-01-26

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

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

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To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.

Detailed Description

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Conditions

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Critically Ill Mechanically Ventilated Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention Group

Peptamen Bariatric

Group Type EXPERIMENTAL

Peptamen Bariatric

Intervention Type OTHER

Commercially available enteral diet

Control Group

Replete

Group Type ACTIVE_COMPARATOR

Replete

Intervention Type OTHER

Commercially available enteral diet

Interventions

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Peptamen Bariatric

Commercially available enteral diet

Intervention Type OTHER

Replete

Commercially available enteral diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* New admit to the ICU and expected to remain in ICU 5 days
* Ventilator dependent up to 48 hours prior to admission to the study
* Requiring tube feeding enteral nutrition (EN) 5 days
* Expected to receive 50% of caloric needs within 72 hours
* Body Mass Index 26-45

Exclusion Criteria

* Trauma patients
* Major surgery in past 30 days or planned for next 7 days
* Diabetes mellitus (DM) type 1
* Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis
* Pregnant or lactating
* Non-functioning GI tract
* Use of parenteral nutrition in past 30 days
* Admitted with burns \> 20% body surface area
* Traumatic brain injury
* Hemodynamic instability that prevents delivery of EN \> 24hr
* Unable to access GI tract for feeding via tube, unable to receive EN
* Other contraindication to tube feeding
* Any other condition that would not allow patient to complete the study protocol
* Use of enteral formula at enrollment that cannot be changed to the investigational product
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

University of Chicago Medicine

Chicago, Illinois, United States

Site Status

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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13.23.CLI

Identifier Type: -

Identifier Source: org_study_id

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