<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/NCT02212665</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2013-079</org_study_id>
    <nct_id>NCT02212665</nct_id>
  </id_info>
  <brief_title>Life Without Diabetes</brief_title>
  <official_title>Life Without Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study 'Live - without diabetes' is to investigate the effects of increased&#xD;
      physical activity on a daily basis with or without (high intense interval training) HIIT&#xD;
      (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 125 individuals with pre-diabetes will be included and randomized into four&#xD;
      different groups (N=25, each group): 1) Increased daily activity detected by the pedometer,&#xD;
      2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily&#xD;
      activity detected by the pedometer + group intervention 5) a control group (maintain&#xD;
      unchanged activity and life-style during the duration of the study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in insulin sensitivity</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in oxygen peak oxygen uptake</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Assessed from a physical fitness test (VO2peak)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glycaemic control</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Measured as fasting plasma glucose, HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in key proteins in glucose and fat metabolism (Skeletal muscle)</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Expression/content of key proteins in skeletal muscle tissure (AU units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight (kg)</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Measured by Dual-energy X-ray Absorptiometry, DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Expression/content of key proteins in adipose tissue (AU units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome measure</measure>
    <time_frame>At baseline and after 12 weeks</time_frame>
    <description>Health related quality of life measured from Short Form 36 (SF36). Where scores are presented as norm-based scores (0-100) with higher scores indicating better perceived health status.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Prevention of Developing Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>High intense interval training (HIIT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 x 20 sec, 3 x week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased daily activity detected by the pedometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10.000 steps a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased daily activity detected by te pedometer+HIIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10.000 steps + 3 x 20 sec, 3 x week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased daily activity (pedometer)+group intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10.000 steps + group intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intense interval training</intervention_name>
    <arm_group_label>High intense interval training (HIIT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increased daily activity detected by the pedometer</intervention_name>
    <arm_group_label>Increased daily activity detected by the pedometer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increased daily activity detected by the pedometer+HIIT</intervention_name>
    <arm_group_label>Increased daily activity detected by te pedometer+HIIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increased daily activity detected by the pedometer+group intervention</intervention_name>
    <arm_group_label>Increased daily activity (pedometer)+group intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 25 kg/m2&#xD;
&#xD;
          -  Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased&#xD;
             fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose&#xD;
             tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol)&#xD;
&#xD;
          -  Weekly training status &lt;150 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;25 kg/m2&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#xD;
&#xD;
          -  Treatment with medicine, there influence glucose metabolism&#xD;
&#xD;
          -  Decreased liver function (liver transaminases &gt; 3 times of limit of normal)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Diabetes Research, Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 5, 2021</last_update_submitted>
  <last_update_submitted_qc>July 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Pernille Mensberg</investigator_full_name>
    <investigator_title>MSc, ph.d-student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02212665
org study id: H-4-2013-079
nct id: NCT02212665
lead sponsor: 
has dmc: No
The aim of the study 'Live - without diabetes' is to investigate the effects of increased
      physical activity on a daily basis with or without (high intense interval training) HIIT
      (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes
A total of 125 individuals with pre-diabetes will be included and randomized into four
      different groups (N=25, each group): 1) Increased daily activity detected by the pedometer,
      2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily
      activity detected by the pedometer + group intervention 5) a control group (maintain
      unchanged activity and life-style during the duration of the study).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in insulin sensitivity
time frame: At baseline and after 12 weeks
description: The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index
measure: Changes in oxygen peak oxygen uptake
time frame: At baseline and after 12 weeks
description: Assessed from a physical fitness test (VO2peak)
measure: Changes in glycaemic control
time frame: At baseline and after 12 weeks
description: Measured as fasting plasma glucose, HbA1c
measure: Changes in key proteins in glucose and fat metabolism (Skeletal muscle)
time frame: At baseline and after 12 weeks
description: Expression/content of key proteins in skeletal muscle tissure (AU units)
measure: Changes in body weight (kg)
time frame: At baseline and after 12 weeks
description: Measured by Dual-energy X-ray Absorptiometry, DXA
measure: Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)
time frame: At baseline and after 12 weeks
description: Expression/content of key proteins in adipose tissue (AU units)
measure: Patient-reported outcome measure
time frame: At baseline and after 12 weeks
description: Health related quality of life measured from Short Form 36 (SF36). Where scores are presented as norm-based scores (0-100) with higher scores indicating better perceived health status.
arm group label: High intense interval training (HIIT)
arm group type: Experimental
description: 3 x 20 sec, 3 x week
arm group label: Increased daily activity detected by the pedometer
arm group type: Experimental
description: 10.000 steps a day
arm group label: Increased daily activity detected by te pedometer+HIIT
arm group type: Experimental
description: 10.000 steps + 3 x 20 sec, 3 x week
arm group label: Increased daily activity (pedometer)+group intervention
arm group type: Experimental
description: 10.000 steps + group intervention
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: High intense interval training
arm group label: High intense interval training (HIIT)
intervention type: Behavioral
intervention name: Increased daily activity detected by the pedometer
arm group label: Increased daily activity detected by the pedometer
intervention type: Behavioral
intervention name: Increased daily activity detected by the pedometer+HIIT
arm group label: Increased daily activity detected by te pedometer+HIIT
intervention type: Behavioral
intervention name: Increased daily activity detected by the pedometer+group intervention
arm group label: Increased daily activity (pedometer)+group intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Pernille Mensberg
investigator title: MSc, ph.d-student
mesh term: Diabetes Mellitus