<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/NCT04456166</url>
  </required_header>
  <id_info>
    <org_study_id>20030471108</org_study_id>
    <nct_id>NCT04456166</nct_id>
  </id_info>
  <brief_title>Safety of Preoperative Carbohydrate Loading in Diabetic Patients</brief_title>
  <acronym>NoNPO</acronym>
  <official_title>Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to investigate the safety of preoperative carbohydrate loading&#xD;
      in diabetic patients undergoing general anesthesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">May 4, 2021</completion_date>
  <primary_completion_date type="Actual">May 4, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of gastric ultrasonography score as low risk (grade 0 or 1)</measure>
    <time_frame>30 minutes after intubation</time_frame>
    <description>Ultrasound assessment of gastric volume by gastroscopic examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric volume</measure>
    <time_frame>30 minutes after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sugar test</measure>
    <time_frame>30 minutes after intubation and 30 minutes after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of insulin bolus injection</measure>
    <time_frame>during operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of insulin bolus injection</measure>
    <time_frame>up to 30 minutes after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction scale of patients</measure>
    <time_frame>up to 30 minutes after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of nausea and vomiting</measure>
    <time_frame>up to 30 minutes after extubation</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Carbohydrate Intolerance</condition>
  <condition>Diabetes Mellitus Type 2</condition>
  <arm_group>
    <arm_group_label>Patient who received carbohydrate loading</arm_group_label>
    <description>Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>noNPO</intervention_name>
    <description>Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.&#xD;
Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography.</description>
    <arm_group_label>Patient who received carbohydrate loading</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years of age who are scheduled to undergo general anesthesia are subject&#xD;
        to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral&#xD;
        hypoglycemic agents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  Type 2 diabetes mellitus on oral hypoglycemic agents&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status 2 or 3&#xD;
&#xD;
          -  Ages 18 or more&#xD;
&#xD;
          -  Approve to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ambulatory surgery&#xD;
&#xD;
          -  BMI &gt;35&#xD;
&#xD;
          -  History of gastric or esophagus surgery&#xD;
&#xD;
          -  History of GERD, dyspepesia or&#xD;
&#xD;
          -  Anticipated difficult intubation (previous III or more Cormack and Lehane's grade,&#xD;
             Mallamgrade, Mallampati scpati scoreore III or moreIII or more,&#xD;
             propro/retro/retrognathism, gnathism, thyromental distance&lt;6.5cm, thyromental&#xD;
             distance&lt;6.5cm, limited mouth openinglimited mouth opening)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Susie Yoon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongnogu</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Susie Yoon</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Carbohydrate Intolerance</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Carbohydrate loading</keyword>
  <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>Undecided</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/NCT04456166
org study id: 20030471108
nct id: NCT04456166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the safety of preoperative carbohydrate loading
      in diabetic patients undergoing general anesthesia
observational model: Cohort
time perspective: Prospective
measure: Incidence of gastric ultrasonography score as low risk (grade 0 or 1)
time frame: 30 minutes after intubation
description: Ultrasound assessment of gastric volume by gastroscopic examination.
measure: Gastric volume
time frame: 30 minutes after intubation
measure: Blood sugar test
time frame: 30 minutes after intubation and 30 minutes after extubation
measure: The incidence of insulin bolus injection
time frame: during operation
measure: The incidence of insulin bolus injection
time frame: up to 30 minutes after extubation
measure: Satisfaction scale of patients
time frame: up to 30 minutes after extubation
measure: The incidence of nausea and vomiting
time frame: up to 30 minutes after extubation
arm group label: Patient who received carbohydrate loading
description: Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting
intervention type: Dietary Supplement
intervention name: noNPO
description: Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.
Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography.
arm group label: Patient who received carbohydrate loading
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Susie Yoon, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Susie Yoon
investigator title: Clinical Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided