<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/NCT03003507</url>
  </required_header>
  <id_info>
    <org_study_id>v4n3n8xw</org_study_id>
    <nct_id>NCT03003507</nct_id>
  </id_info>
  <brief_title>Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients</brief_title>
  <official_title>Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Moinhos de Vento</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these&#xD;
      patients receive enteral feeding. There is controversy about ideal carbohydrate composition&#xD;
      of these diets. The aim of this study was to compare an enteral formula with the same&#xD;
      proportion of carbohydrates with and without fructose on blood glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult&#xD;
      patients admitted to the ICU who presented capillary glycemia values&gt; 180mg / dl with a full&#xD;
      and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each&#xD;
      diet: with / without fructose). Capillary glycemia was measured 4 / 4h.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2011</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Variability</measure>
    <time_frame>four days</time_frame>
    <description>To evaluate the glycemic oscillation during the use of enteral feedings</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Diet 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-carbohydrate Enteral Formula With Fructose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-carbohydrate Enteral Formula Without Fructose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enteral Formula With Fructose</intervention_name>
    <description>Low-carbohydrate Enteral Formula With Fructose</description>
    <arm_group_label>Diet 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enteral Formula Without Fructose</intervention_name>
    <description>Low-carbohydrate Enteral Formula Without Fructose</description>
    <arm_group_label>Diet 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critical Illness&#xD;
&#xD;
          -  Exclusive enteral diet&#xD;
&#xD;
          -  Enteral diet with full nutritional value&#xD;
&#xD;
          -  Hyperglycemia ≥180 mg / dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral feeding&#xD;
&#xD;
          -  NPT (Total or Partial Parenteral Nutrition)&#xD;
&#xD;
          -  Patient without indication of use of study diets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Moinhos de Vento</investigator_affiliation>
    <investigator_full_name>Magali Kumbier</investigator_full_name>
    <investigator_title>Nutritionist</investigator_title>
  </responsible_party>
  <keyword>Hyperglycemia</keyword>
  <keyword>Fructose</keyword>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Enteral Nutrition</keyword>
  <keyword>Glycemic Variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03003507
org study id: v4n3n8xw
nct id: NCT03003507
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Glycemic Variability
time frame: four days
description: To evaluate the glycemic oscillation during the use of enteral feedings
arm group label: Diet 1
arm group type: Active Comparator
description: Low-carbohydrate Enteral Formula With Fructose
arm group label: Diet 2
arm group type: Active Comparator
description: Low-carbohydrate Enteral Formula Without Fructose
intervention type: Dietary Supplement
intervention name: Enteral Formula With Fructose
description: Low-carbohydrate Enteral Formula With Fructose
arm group label: Diet 1
intervention type: Dietary Supplement
intervention name: Enteral Formula Without Fructose
description: Low-carbohydrate Enteral Formula Without Fructose
arm group label: Diet 2
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Moinhos de Vento
investigator full name: Magali Kumbier
investigator title: Nutritionist
mesh term: Critical Illness
sharing ipd: No