<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/NCT04495114</url>
  </required_header>
  <id_info>
    <org_study_id>RES0034025</org_study_id>
    <nct_id>NCT04495114</nct_id>
  </id_info>
  <brief_title>Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery</brief_title>
  <official_title>Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Goal to evaluate the feasibility of conducting a large study that would assess the safety of&#xD;
      carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2&#xD;
      diabetes.&#xD;
&#xD;
      Traditionally, prior to surgeries involving 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.&#xD;
&#xD;
      It is currently not known if it is safe for patients with type 2 diabetes to have a sugar&#xD;
      drink before their surgery since they have trouble processing sugars and a subset of patients&#xD;
      with diabetes are at increased risk to aspiration due to delayed gastric emptying.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fasting prior to the administration of a general anesthetic has been the standard of&#xD;
      peri-operative care for many years. The refrain of &quot;nothing to eat or drink after midnight&quot;&#xD;
      has become synonymous with surgery for both clinicians and the general public. The rationale&#xD;
      behind this practice has been to reduce the risk of regurgitation of gastric contents. In&#xD;
      addition, this instruction is straightforward for patients and ancillary staff, and allows&#xD;
      for easy alteration of the order of cases on the operative list. Despite the widespread&#xD;
      nature of this practice, a 2003 Cochrane review attempted to define the optimum duration of&#xD;
      fasting, type of fasting, and volume of intake permitted and concluded that there was no&#xD;
      evidence to suggest a shortened fluid fast resulted in an increased risk of aspiration,&#xD;
      regurgitation, or morbidity in healthy patients.&#xD;
&#xD;
      Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it&#xD;
      has been suggested that a preoperative carbohydrate loading may alleviate some deleterious&#xD;
      effects of this fast. This strategy, combined with a number of others, have been recently&#xD;
      introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved&#xD;
      postoperative pain, faster restoration of GI function, decreased LOS and decreased&#xD;
      complication rate after colon surgery.&#xD;
&#xD;
      Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that&#xD;
      affects over 15% of general surgical patients undergoing major abdominal surgery. It is well&#xD;
      recognized that this is a high-risk surgical population that is at increased risk of&#xD;
      perioperative complications such as anastomotic dehiscence, poor wound healing, and&#xD;
      postoperative ileus which can lead to an increased LOS after surgery. However, there is a&#xD;
      relative dearth of robust evidence regarding preoperative fasting in patients with type 2&#xD;
      diabetes so there is no consensus among professional association guidelines internationally&#xD;
      on recommendations for carbohydrate loading in this population undergoing elective surgery.&#xD;
      Two major concerns have been raised; first the risk of aspiration in diabetic patients with a&#xD;
      significant neuropathy and gastroparesis, and second potential for hyperglycemia and its&#xD;
      deleterious effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative glucose</measure>
    <time_frame>1 to 2 hours prior to operation time.</time_frame>
    <description>Mean difference in preoperative glucose between the two groups</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Modern fasting guidelines without the carbohydrate load preoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40g carbohydrate load preoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>40g carbohydrate load (Apple juice)</intervention_name>
    <description>A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes, non-insulin dependent.&#xD;
&#xD;
          -  Elective colorectal surgery patient at the University of Alberta Hospital, Grey Nuns&#xD;
             Hospital, Misericordia Hospital, Foothills Hospital, or Royal Alexandra Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin dependent type 2 diabetes&#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>Haili Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alberta Health services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</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>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04495114
org study id: RES0034025
nct id: NCT04495114
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Goal 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 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.

      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 to aspiration due to delayed gastric emptying.
Fasting prior to the administration of a general anesthetic has been the standard of
      peri-operative care for many years. The refrain of "nothing to eat or drink after midnight"
      has become synonymous with surgery for both clinicians and the general public. The rationale
      behind this practice has been to reduce the risk of regurgitation of gastric contents. In
      addition, this instruction is straightforward for patients and ancillary staff, and allows
      for easy alteration of the order of cases on the operative list. Despite the widespread
      nature of this practice, a 2003 Cochrane review attempted to define the optimum duration of
      fasting, type of fasting, and volume of intake permitted and concluded that there was no
      evidence to suggest a shortened fluid fast resulted in an increased risk of aspiration,
      regurgitation, or morbidity in healthy patients.

      Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it
      has been suggested that a preoperative carbohydrate loading may alleviate some deleterious
      effects of this fast. This strategy, combined with a number of others, have been recently
      introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved
      postoperative pain, faster restoration of GI function, decreased LOS and decreased
      complication rate after colon surgery.

      Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that
      affects over 15% of general surgical patients undergoing major abdominal surgery. It is well
      recognized that this is a high-risk surgical population that is at increased risk of
      perioperative complications such as anastomotic dehiscence, poor wound healing, and
      postoperative ileus which can lead to an increased LOS after surgery. However, there is a
      relative dearth of robust evidence regarding preoperative fasting in patients with type 2
      diabetes so there is no consensus among professional association guidelines internationally
      on recommendations for carbohydrate loading in this population undergoing elective surgery.
      Two major concerns have been raised; first the risk of aspiration in diabetic patients with a
      significant neuropathy and gastroparesis, and second potential for hyperglycemia and its
      deleterious effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Care Provider, Investigator)
measure: Preoperative glucose
time frame: 1 to 2 hours prior to operation time.
description: Mean difference in preoperative glucose between the two groups
arm group label: Control Arm
arm group type: No Intervention
description: Modern fasting guidelines without the carbohydrate load preoperatively.
arm group label: Intervention Arm
arm group type: Experimental
description: 40g carbohydrate load preoperatively.
intervention type: Other
intervention name: 40g carbohydrate load (Apple juice)
description: A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Haili Wang, MD
role: Principal Investigator
affiliation: Alberta Health services
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)