<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/NCT02204839</url>
  </required_header>
  <id_info>
    <org_study_id>West-Walker3</org_study_id>
    <nct_id>NCT02204839</nct_id>
  </id_info>
  <brief_title>Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM</brief_title>
  <official_title>The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,&#xD;
      Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate&#xD;
      feeding and rapid-acting insulin dose recommendations will protect patients with type 1&#xD;
      diabetes from early- and late-onset hypoglycaemia following evening time exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour blood glucose area under the curve</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour blood glucose area under the curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ketonaemia</measure>
    <time_frame>60 minutes before and 24 hours post-exercise</time_frame>
    <description>Blood beta-hydroxybutyrate concentrations</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Basal dose reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basal insulin dose</intervention_name>
    <arm_group_label>Basal dose reduction</arm_group_label>
    <other_name>(Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18-50 years old (male or female).&#xD;
&#xD;
          -  Free from any diabetes related complications (apart from mild background diabetic&#xD;
             retinopathy).&#xD;
&#xD;
          -  HbA1c &lt;8.5%.&#xD;
&#xD;
          -  Not taking any prescribed medication other than insulin, and treated with a stable&#xD;
             insulin regimen composed of a combination of slow/long acting insulin (glargine or&#xD;
             detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6&#xD;
             months before the start of the study.&#xD;
&#xD;
          -  Demonstrate normal cardiac function in response to exercise.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged younger than 18, or older than 50 years.&#xD;
&#xD;
          -  Suffering from, or diagnosed with a diabetes related complication (apart from mild&#xD;
             background diabetic retinopathy).&#xD;
&#xD;
          -  HbA1c &gt;8.5%.&#xD;
&#xD;
          -  Currently taking prescribed medication, and not currently treated with a stable basal&#xD;
             bolus regimen composed of a combination glargine or determir, and lispro or aspart for&#xD;
             at least 6 months before the start of the study.&#xD;
&#xD;
          -  Failure to demonstrate normal cardiopulmonary responses during exercise, or have a&#xD;
             medical condition which could prevent completion of exercise or be exacerbated because&#xD;
             of.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel J West, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Facility, Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>January 14, 2015</last_update_submitted>
  <last_update_submitted_qc>January 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T1DM, Exercise, Hypoglycaemia</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 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin Detemir</mesh_term>
  </intervention_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/NCT02204839
org study id: West-Walker3
nct id: NCT02204839
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,
      Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate
      feeding and rapid-acting insulin dose recommendations will protect patients with type 1
      diabetes from early- and late-onset hypoglycaemia following evening time exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: 24 hour blood glucose area under the curve
time frame: 24 hours
description: 24 hour blood glucose area under the curve
measure: Ketonaemia
time frame: 60 minutes before and 24 hours post-exercise
description: Blood beta-hydroxybutyrate concentrations
arm group label: Basal dose reduction
arm group type: Experimental
description: Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.
intervention type: Drug
intervention name: Basal insulin dose
arm group label: Basal dose reduction
other name: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Daniel J West, PhD
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin Glargine
mesh term: Insulin Detemir