Enteral Nutrition and Glucose Homeostasis

January 5, 2017 updated by: Marlene Wewalka, Medical University of Vienna

Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess whether enteral nutrition fomulas based either on fat or glucose influence glucose homeostasis differently in critically ill medical patients. All patients are admitted to a tertiary ICU and require mechanical ventilation.

Resting energy expenditure is assessed at baseline in the fasting state by indirect calorimetry. Total energy demand is calculated and patients are randomized to receive fat-based or glucose-based nutrition which is administered continously for 7 days. Indirect calorimetry is repeated on days 3 and 7 under continous nutrition. During the study period, various parameters of glucose homeostasis are assessed. Daily, there will be at least 3 measurements of blood glucose, more if the treating physician deems it necessary. Daily average glucose, daily glucose variability, overall area under the curve for glucose are calculated. Furthermore, energy intake by nutrition, medications (i.e. propofol), and glucose infusion, as well as substrate intake, and insulin demand per 24hrs are determined daily. Adverse effects such as episodes of hyper- or hypoglycemia, cholestasis, hypertriglyceridemia, diarrhea, vomiting, and the amount of gastric residual volume are noted.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical patient with need for mechanical ventilation
  • FiO2 requirement < 60%
  • need for nutritional support

Exclusion Criteria:

  • contraindications against nutritional therapy
  • hemodynamic shock (lactate of ≥ 4 mmol/l)
  • severe hypertriglyceridemia (≥ 450 mg/dl)
  • contraindications against enteral nutrion (intestinal obstruction, disruption or severe bleeding of upper gastrointestinal tract)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fat-based
Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU
Other: Diben, Fresenius Kabi
Patients receive Diben continously for 7 days
Active Comparator: glucose-based
Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU
Other: Fresubin original fibre, Fresenius Kabi
Patients receive Fresubin original fibre continously for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average daily glucose
Time Frame: up to 7 days
up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
insulin demand per 24 hrs
Time Frame: up to 7 days
up to 7 days
glucose variability
Time Frame: up to 7 days
up to 7 days
nutrition-related side effects
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Zauner, MD, Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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