<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/NCT04410419</url>
  </required_header>
  <id_info>
    <org_study_id>Carbs Drink in Colorectal</org_study_id>
    <nct_id>NCT04410419</nct_id>
  </id_info>
  <brief_title>Carbohydrate Loading and Diabetes in Colorectal Surgery</brief_title>
  <official_title>In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the feasibility of conducting a large study that would&#xD;
      assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in&#xD;
      patients with type 2 diabetes.&#xD;
&#xD;
      Traditionally, prior to surgeries involving a general anesthetic, patients have been told not&#xD;
      to eat or drink anything after midnight due to the risk of aspiration. More recent research&#xD;
      have shown that it is safe to have clear fluids up to 2 hours before an operation and this is&#xD;
      reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that&#xD;
      subjecting patients to a state of starvation causes stress on the body that may lead to&#xD;
      complications such as poor wound healing, infections, and delayed return to bowel function. A&#xD;
      sugar drink before surgery has been shown to be beneficial and can lead to decreased&#xD;
      complication rates and decreased length of stay after surgery.&#xD;
&#xD;
      However, it is currently not known if it is safe for patients with type 2 diabetes to have a&#xD;
      sugar drink before their surgery since they have trouble processing sugars and a subset of&#xD;
      patients with diabetes are at increased risk of aspiration due to delayed stomach emptying.&#xD;
&#xD;
      This feasibility study is designed to answer the question of whether a large scale trial can&#xD;
      be conducted examining the benefits of a pre-operative sugar drink in patients with type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference of preoperative glucose between the two groups</measure>
    <time_frame>Pre-operative</time_frame>
    <description>Examined in a non-inferiority fashion with NI margin set as 2mmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite outcome of diabetes-related complications</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>How long the patient stays in hospital after surgery in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>Whether a wound infection is noted in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications using the Clavien Dindo scale</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative serum blood glucose concentration</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>Serum blood glucose compiled on a daily basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of peri-operative insulin use</measure>
    <time_frame>Within 30 days of surgery or to discharge</time_frame>
    <description>Whether insulin or an insulin infusion in the peri-operative period is used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Surgery</condition>
  <condition>Surgery--Complications</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care for patients with diabetes pre-operatively .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pre-operative carbohydrate drink</intervention_name>
    <description>Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery</description>
    <arm_group_label>Carbohydrate drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult (&gt;=18 years of age) patients with an established diagnosis of type 2&#xD;
             diabetes mellitus undergoing elective colorectal surgery at the University of Alberta&#xD;
             Hospital, the Grey Nuns Hospital, the Royal Alexandra Hospital or the Misericordia&#xD;
             Hospital will be eligible. Only patients treated with diet or oral hypoglycemic agents&#xD;
             will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects &lt;18 years of age, and those on insulin therapy preoperatively will be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04410419
org study id: Carbs Drink in Colorectal
nct id: NCT04410419
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate the feasibility of conducting a large study that would
      assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in
      patients with type 2 diabetes.

      Traditionally, prior to surgeries involving a general anesthetic, patients have been told not
      to eat or drink anything after midnight due to the risk of aspiration. More recent research
      have shown that it is safe to have clear fluids up to 2 hours before an operation and this is
      reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that
      subjecting patients to a state of starvation causes stress on the body that may lead to
      complications such as poor wound healing, infections, and delayed return to bowel function. A
      sugar drink before surgery has been shown to be beneficial and can lead to decreased
      complication rates and decreased length of stay after surgery.

      However, it is currently not known if it is safe for patients with type 2 diabetes to have a
      sugar drink before their surgery since they have trouble processing sugars and a subset of
      patients with diabetes are at increased risk of aspiration due to delayed stomach emptying.

      This feasibility study is designed to answer the question of whether a large scale trial can
      be conducted examining the benefits of a pre-operative sugar drink in patients with type 2
      diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Mean difference of preoperative glucose between the two groups
time frame: Pre-operative
description: Examined in a non-inferiority fashion with NI margin set as 2mmol/L
measure: Composite outcome of diabetes-related complications
time frame: Within 30 days of surgery or to discharge
description: hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration
measure: length of stay
time frame: Within 30 days of surgery or to discharge
description: How long the patient stays in hospital after surgery in days
measure: Surgical site infection
time frame: Within 30 days of surgery or to discharge
description: Whether a wound infection is noted in hospital
measure: Postoperative complications using the Clavien Dindo scale
time frame: Within 30 days of surgery or to discharge
description: A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.
measure: Post-operative serum blood glucose concentration
time frame: Within 30 days of surgery or to discharge
description: Serum blood glucose compiled on a daily basis
measure: Rate of peri-operative insulin use
time frame: Within 30 days of surgery or to discharge
description: Whether insulin or an insulin infusion in the peri-operative period is used
arm group label: Standard Care
arm group type: No Intervention
description: Standard care for patients with diabetes pre-operatively .
arm group label: Carbohydrate drink
arm group type: Experimental
description: Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
intervention type: Dietary Supplement
intervention name: Pre-operative carbohydrate drink
description: Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
arm group label: Carbohydrate drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No