<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/NCT02982330</url>
  </required_header>
  <id_info>
    <org_study_id>H16--00377</org_study_id>
    <nct_id>NCT02982330</nct_id>
  </id_info>
  <brief_title>Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes</brief_title>
  <official_title>Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to&#xD;
      sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is&#xD;
      known to reduce post-meal glucose excursions but it is unknown whether lowering the&#xD;
      carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout&#xD;
      the day. The aim of this study is to examine, under free living conditions and using typical&#xD;
      dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal&#xD;
      glycemia when compared to consuming a low-fat breakfast (per the current diabetes&#xD;
      guidelines).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incremental area under the glucose curve (continuous glucose monitor)</measure>
    <time_frame>24 hour (one day)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Blod Glucose (continuous glucose monitor)</measure>
    <time_frame>24 hours (one day)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Glycemic Variability (continuous glucose monitor)</measure>
    <time_frame>24 hours (one day)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Satiety VAS 100</measure>
    <time_frame>Before and after meals (one day)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Low Carbohydrate Breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breakfast composition containing &lt;10% carbohydrate, 75% fat, 15% protein Matched calories</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guidelines Breakfast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Carbohydrate Breakfast</intervention_name>
    <description>A low carbohydrate breakfast containing &lt;10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.</description>
    <arm_group_label>Guidelines Breakfast</arm_group_label>
    <arm_group_label>Low Carbohydrate Breakfast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guidelines Breakfast</intervention_name>
    <description>A low fat breakfast containing ~55% carbohydrate, &lt;30% fat, and 15% protein. Matched for calories to the experimental arm.</description>
    <arm_group_label>Guidelines Breakfast</arm_group_label>
    <arm_group_label>Low Carbohydrate Breakfast</arm_group_label>
    <other_name>Low-fat Breakfast</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician-diagnosed Type 2 Diabetes (&gt;6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exogenous Insulin&#xD;
&#xD;
          -  A1c &gt; 9%&#xD;
&#xD;
          -  Cardiovascular, liver, or renal other disease&#xD;
&#xD;
          -  Breakfast and meal skippers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan P Little, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UBC Okanagan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia, Okanagan.</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1V 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Jonathan Little</investigator_full_name>
    <investigator_title>Dr Jonathan P Little</investigator_title>
  </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>
  <!-- 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/NCT02982330
org study id: H16--00377
nct id: NCT02982330
lead sponsor: 
has dmc: No
Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to
      sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is
      known to reduce post-meal glucose excursions but it is unknown whether lowering the
      carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout
      the day. The aim of this study is to examine, under free living conditions and using typical
      dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal
      glycemia when compared to consuming a low-fat breakfast (per the current diabetes
      guidelines).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incremental area under the glucose curve (continuous glucose monitor)
time frame: 24 hour (one day)
measure: Mean Blod Glucose (continuous glucose monitor)
time frame: 24 hours (one day)
measure: Glycemic Variability (continuous glucose monitor)
time frame: 24 hours (one day)
measure: Satiety VAS 100
time frame: Before and after meals (one day)
arm group label: Low Carbohydrate Breakfast
arm group type: Experimental
description: Breakfast composition containing <10% carbohydrate, 75% fat, 15% protein Matched calories
arm group label: Guidelines Breakfast
arm group type: Active Comparator
description: Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories
intervention type: Behavioral
intervention name: Low Carbohydrate Breakfast
description: A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.
arm group label: Guidelines Breakfast
arm group label: Low Carbohydrate Breakfast
intervention type: Behavioral
intervention name: Guidelines Breakfast
description: A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.
arm group label: Guidelines Breakfast
arm group label: Low Carbohydrate Breakfast
other name: Low-fat Breakfast
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jonathan P Little, PhD
role: Principal Investigator
affiliation: UBC Okanagan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Jonathan Little
investigator title: Dr Jonathan P Little
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2