<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03012867</url>
  </required_header>
  <id_info>
    <org_study_id>NUTR1</org_study_id>
    <nct_id>NCT03012867</nct_id>
  </id_info>
  <brief_title>Enteral Nutrition and Glucose Homeostasis</brief_title>
  <official_title>Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Different enteral nutrition formulas are tested on their effect on glucose homeostasis in&#xD;
      critically ill medical patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess whether enteral nutrition fomulas based either on fat or glucose influence glucose&#xD;
      homeostasis differently in critically ill medical patients. All patients are admitted to a&#xD;
      tertiary ICU and require mechanical ventilation.&#xD;
&#xD;
      Resting energy expenditure is assessed at baseline in the fasting state by indirect&#xD;
      calorimetry. Total energy demand is calculated and patients are randomized to receive&#xD;
      fat-based or glucose-based nutrition which is administered continously for 7 days. Indirect&#xD;
      calorimetry is repeated on days 3 and 7 under continous nutrition. During the study period,&#xD;
      various parameters of glucose homeostasis are assessed. Daily, there will be at least 3&#xD;
      measurements of blood glucose, more if the treating physician deems it necessary. Daily&#xD;
      average glucose, daily glucose variability, overall area under the curve for glucose are&#xD;
      calculated. Furthermore, energy intake by nutrition, medications (i.e. propofol), and glucose&#xD;
      infusion, as well as substrate intake, and insulin demand per 24hrs are determined daily.&#xD;
      Adverse effects such as episodes of hyper- or hypoglycemia, cholestasis,&#xD;
      hypertriglyceridemia, diarrhea, vomiting, and the amount of gastric residual volume are&#xD;
      noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>average daily glucose</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>insulin demand per 24 hrs</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glucose variability</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nutrition-related side effects</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hyperglycemia Stress</condition>
  <arm_group>
    <arm_group_label>fat-based</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glucose-based</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diben, Fresenius Kabi</intervention_name>
    <description>Patients receive Diben continously for 7 days</description>
    <arm_group_label>fat-based</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fresubin original fibre, Fresenius Kabi</intervention_name>
    <description>Patients receive Fresubin original fibre continously for 7 days</description>
    <arm_group_label>glucose-based</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical patient with need for mechanical ventilation&#xD;
&#xD;
          -  FiO2 requirement &lt; 60%&#xD;
&#xD;
          -  need for nutritional support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications against nutritional therapy&#xD;
&#xD;
          -  hemodynamic shock (lactate of ≥ 4 mmol/l)&#xD;
&#xD;
          -  severe hypertriglyceridemia (≥ 450 mg/dl)&#xD;
&#xD;
          -  contraindications against enteral nutrion (intestinal obstruction, disruption or&#xD;
             severe bleeding of upper gastrointestinal tract)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Zauner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Marlene Wewalka</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>criticall illness</keyword>
  <keyword>enteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012867
org study id: NUTR1
nct id: NCT03012867
lead sponsor: 
has dmc: No
Different enteral nutrition formulas are tested on their effect on glucose homeostasis in
      critically ill medical patients.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: average daily glucose
time frame: up to 7 days
measure: insulin demand per 24 hrs
time frame: up to 7 days
measure: glucose variability
time frame: up to 7 days
measure: nutrition-related side effects
time frame: 7 days
arm group label: fat-based
arm group type: Active Comparator
description: Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU
arm group label: glucose-based
arm group type: Active Comparator
description: Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU
intervention type: Other
intervention name: Diben, Fresenius Kabi
description: Patients receive Diben continously for 7 days
arm group label: fat-based
intervention type: Other
intervention name: Fresubin original fibre, Fresenius Kabi
description: Patients receive Fresubin original fibre continously for 7 days
arm group label: glucose-based
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Zauner, MD
role: Principal Investigator
affiliation: Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Marlene Wewalka
investigator title: MD
mesh term: Hyperglycemia
sharing ipd: No