The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
NCT ID: NCT02337556
Last Updated: 2018-01-26
Study Results
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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COMPLETED
NA
106 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Intervention Group
Peptamen Bariatric
Peptamen Bariatric
Commercially available enteral diet
Control Group
Replete
Replete
Commercially available enteral diet
Interventions
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Peptamen Bariatric
Commercially available enteral diet
Replete
Commercially available enteral diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Emory University Hospital
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, United States
Regions Hospital
Saint Paul, Minnesota, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Queen's University
Kingston, Ontario, Canada
Countries
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Other Identifiers
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13.23.CLI
Identifier Type: -
Identifier Source: org_study_id
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