<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/NCT04418869</url>
  </required_header>
  <id_info>
    <org_study_id>251981</org_study_id>
    <nct_id>NCT04418869</nct_id>
  </id_info>
  <brief_title>Exercise in Adolescents With Type 1 Diabetes</brief_title>
  <official_title>Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Örebro County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Örebro County</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>
      Regular physical activity is an important part of diabetes management in adolescents with&#xD;
      type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as&#xD;
      improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c&#xD;
      is often seen in association to increased physical activity. However, the effect on glycemic&#xD;
      control and the acute glycemic response seems to differs between different types of exercise.&#xD;
      This issue is poorly studied in adolescents with T1D and the mechanism behind this is not&#xD;
      fully understood.&#xD;
&#xD;
      The primary aim of this study was to compare the acute effects on glycemia of resistance and&#xD;
      two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes.&#xD;
      Secondarily, the investigators want to compare the different exercise according to hormonal&#xD;
      changes and expression of mRNA in muscle.&#xD;
&#xD;
      At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and&#xD;
      maximal strength (1-RM). The study participants then performed three exercise bouts and one&#xD;
      control session (resting), each on 45 minutes, in a randomized order. Measurement was&#xD;
      performed during and after the exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">June 27, 2016</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>Change in plasma glucose during exercise and recovery</measure>
    <time_frame>Plasma glucose were measured at 5 minutes before and at start of the bouts. Thereafter glucose was measured at 5,10,15,30 and 45 minutes during exercise. In addition glucose were measured at 15, 30, 45 and 60 minutes during the initial recovery period.</time_frame>
    <description>Plasma glucose (mmol/l) measured by an hand-held glucometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensor glucose</measure>
    <time_frame>Blinded continuous glucose measurement was started when the exercise bouts were finished and were there after used during the next 22 hours (until the next morning at 08:00 am).</time_frame>
    <description>Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in levels of hormones during exercise and recovery</measure>
    <time_frame>Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis</time_frame>
    <description>Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.</measure>
    <time_frame>One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.</time_frame>
    <description>mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.</measure>
    <time_frame>One biopsy was collected appr. 60 minutes after each exercise bout.</time_frame>
    <description>mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate during exercise.</measure>
    <time_frame>Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).</time_frame>
    <description>Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin saturation during exercise.</measure>
    <time_frame>Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).</time_frame>
    <description>Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output.</measure>
    <time_frame>Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).</time_frame>
    <description>Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subject will perform three different exercise bouts and one control session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise bouts</intervention_name>
    <description>Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  HbA1c &lt; 65 mol/mol at inclusion&#xD;
&#xD;
          -  Regularly performing physical activity&#xD;
&#xD;
          -  Aged 16-18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 0.5 U/kg in insulin requirements&#xD;
&#xD;
          -  Duration of diabetes less than one year.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gender is based on personal identity number and self-identification.</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fawzi Kadi, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>School of health Sciences, Örebro University, Sweden</affiliation>
  </overall_official>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>Exercise</keyword>
  <keyword>Adolescents</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>
  <patient_data>
    <sharing_ipd>No</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/NCT04418869
org study id: 251981
nct id: NCT04418869
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Regular physical activity is an important part of diabetes management in adolescents with
      type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as
      improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c
      is often seen in association to increased physical activity. However, the effect on glycemic
      control and the acute glycemic response seems to differs between different types of exercise.
      This issue is poorly studied in adolescents with T1D and the mechanism behind this is not
      fully understood.

      The primary aim of this study was to compare the acute effects on glycemia of resistance and
      two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes.
      Secondarily, the investigators want to compare the different exercise according to hormonal
      changes and expression of mRNA in muscle.

      At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and
      maximal strength (1-RM). The study participants then performed three exercise bouts and one
      control session (resting), each on 45 minutes, in a randomized order. Measurement was
      performed during and after the exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in plasma glucose during exercise and recovery
time frame: Plasma glucose were measured at 5 minutes before and at start of the bouts. Thereafter glucose was measured at 5,10,15,30 and 45 minutes during exercise. In addition glucose were measured at 15, 30, 45 and 60 minutes during the initial recovery period.
description: Plasma glucose (mmol/l) measured by an hand-held glucometer
measure: Sensor glucose
time frame: Blinded continuous glucose measurement was started when the exercise bouts were finished and were there after used during the next 22 hours (until the next morning at 08:00 am).
description: Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
measure: Changes in levels of hormones during exercise and recovery
time frame: Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
description: Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
measure: Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
time frame: One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
description: mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
measure: Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
time frame: One biopsy was collected appr. 60 minutes after each exercise bout.
description: mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
measure: Change in heart rate during exercise.
time frame: Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
description: Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
measure: Change in hemoglobin saturation during exercise.
time frame: Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
description: Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
measure: Change in cardiac output.
time frame: Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
description: Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
arm group label: Exercise
arm group type: Experimental
description: All subject will perform three different exercise bouts and one control session.
intervention type: Other
intervention name: Exercise bouts
description: Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.
arm group label: Exercise
criteria: 
gender: Male
gender based: Yes
gender description: Gender is based on personal identity number and self-identification.
minimum age: 16 Years
maximum age: 18 Years
healthy volunteers: No
last name: Fawzi Kadi, Professor
role: Study Chair
affiliation: School of health Sciences, Örebro University, Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No