xml: <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/NCT06039787</url>
    </required_header>
    <id_info>
      <org_study_id>226/2023BO2</org_study_id>
      <nct_id>NCT06039787</nct_id>
    </id_info>
    <brief_title>Exercise Training on Brain Insulin Responsiveness</brief_title>
    <acronym>acEx</acronym>
    <official_title>Effects of One Exercise Training Session on Brain Insulin Responsiveness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Tuebingen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Tuebingen</source>
    <oversight_info>
      <has_dmc>No</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 overarching goal of the current study is to investigate the effect of one acute bout of&#xD;
        exercise on the brain insulin responsiveness in a cross-over study design. To this end,&#xD;
        investigators will compare the effect of two single endurance exercise sessions with&#xD;
        different intensities, namely moderate intensity continuous training (MICT) and&#xD;
        high-intensity-interval-training (HIIT), which will be performed in a randomized order. This&#xD;
        will be compared to a waiting control condition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigate one acute bout of exercise on the brain insulin responsiveness using functional&#xD;
        magnetic resonance imaging in combination with intranasal insulin in healthy participants of&#xD;
        normal-weight and overweight/obesity. Two single endurance exercise sessions with different&#xD;
        intensities will be evaluated, namely moderate intensity continuous training (MICT) and&#xD;
        high-intensity interval training (HIIT). This will be compared to a waiting control&#xD;
        condition. In a cross-over design, investigators will compare cerebral response from before&#xD;
        to after intranasal insulin administration after a single bout of HIIT or MICT compared to a&#xD;
        control condition without exercise. Cerebral response is defined as the cerebral blood flow&#xD;
        and resting state functional connectivity in response to intranasal insulin. Secondary&#xD;
        outcomes include changes in blood metabolites and proteins and changes in eating behavior.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>
      <intervention_model_description>In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral response after intranasal insulin administration</measure>
      <time_frame>1 hour after exercise or waiting control</time_frame>
      <description>The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition</measure>
      <time_frame>1 hour after exercise or waiting control</time_frame>
      <description>Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective feeling of hunger and food craving</measure>
      <time_frame>baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control</time_frame>
      <description>Questionnaire assessment before and after exercise or waiting control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Blood-brain barrier integrity</measure>
      <time_frame>1 hour after exercise or waiting control</time_frame>
      <description>Robust multiple echo-time arterial spin labelling based Blood Brain Barrier integrity measurements from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance during cognitive tasks</measure>
      <time_frame>1 hour after exercise or waiting control</time_frame>
      <description>Cambridge Cognition Tests Battery to assess memory and inhibitory control using the paired associates learning task, the pattern recognition memory task and the stop-signal reaction task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in exerkines from plasma samples</measure>
      <time_frame>baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control</time_frame>
      <description>Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in incretins from plasma samples</measure>
      <time_frame>baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control</time_frame>
      <description>Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Insulin Resistance</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>moderate intensity continuous training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>High-intensity interval training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Waiting condition</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>single bout of moderate intensity continuous training (MICT)</intervention_name>
      <description>the MICT consists of 60 min continuous cycling</description>
      <arm_group_label>moderate intensity continuous training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>single bout of High Intensity Interval Training (HIIT)</intervention_name>
      <description>HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover</description>
      <arm_group_label>High-intensity interval training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>waiting control</intervention_name>
      <description>sitting in a waiting room for 60 min</description>
      <arm_group_label>Waiting condition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Normal weight group: BMI between ≥ 19.5 to 24.5 kg/m2&#xD;
  &#xD;
            -  Overweight/Obesity group: BMI between ≥ 27.5 to 39 kg/m2&#xD;
  &#xD;
            -  Less than 150 min/week for moderate-intensity physical activity&#xD;
  &#xD;
            -  Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for&#xD;
               regular physical activity of adults)&#xD;
  &#xD;
            -  Written consent to participate in the study&#xD;
  &#xD;
            -  Written consent to be informed about incidental findings&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial&#xD;
               infarction, status post stroke&#xD;
  &#xD;
            -  Limitations to participate in ergometer-based exercise (balance and coordination&#xD;
               disorders, orthopedic problems, …)&#xD;
  &#xD;
            -  Insufficient knowledge of the German language&#xD;
  &#xD;
            -  Persons who cannot legally give consent&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  History of severe mental or somatic disorders including neurological diseases (incl.&#xD;
               epileptic seizures and migraines)&#xD;
  &#xD;
            -  Taking psychotropic drugs&#xD;
  &#xD;
            -  Taking medications that influence glucose metabolism&#xD;
  &#xD;
            -  Regular use of analgesic drugs&#xD;
  &#xD;
            -  Taking anticoagulant agents&#xD;
  &#xD;
            -  Previous bariatric surgery&#xD;
  &#xD;
            -  Acute infection within the last 4 weeks&#xD;
  &#xD;
            -  Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men&#xD;
  &#xD;
            -  Other diseases that in the opinion of the investigator may jeopardize the success of&#xD;
               the study or indicate a risk to the volunteer&#xD;
  &#xD;
            -  Current participation in a lifestyle intervention study or a pharmaceutical study&#xD;
  &#xD;
            -  Metal implants which cannot be removed as pacemakers, artificial heart valve,&#xD;
               electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth,&#xD;
               contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery&#xD;
  &#xD;
            -  Persons with claustrophobia&#xD;
  &#xD;
            -  Temperature-sensitive person&#xD;
  &#xD;
            -  Persons with tinnitus or increased sensitivity to loud sounds&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andreas L. Birkenfeld, MD</last_name>
      <role>Study Director</role>
      <affiliation>Institute for Diabetes research and Metabolic Diseases at the University of Tubingen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stephanie Kullmann, PhD</last_name>
      <phone>0049707129</phone>
      <phone_ext>87703</phone_ext>
      <email>stephanie.kullmann@med.uni-tuebingen.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Clinic Tübingen, Department of Internal Medicine IV</name>
        <address>
          <city>Tübingen</city>
          <zip>72076</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Exercise</keyword>
    <keyword>functional magnetic resonance imaging</keyword>
    <keyword>Intranasal insulin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin Resistance</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039787
  org study id: 226/2023BO2
  nct id: NCT06039787
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The overarching goal of the current study is to investigate the effect of one acute bout of
        exercise on the brain insulin responsiveness in a cross-over study design. To this end,
        investigators will compare the effect of two single endurance exercise sessions with
        different intensities, namely moderate intensity continuous training (MICT) and
        high-intensity-interval-training (HIIT), which will be performed in a randomized order. This
        will be compared to a waiting control condition.
  Investigate one acute bout of exercise on the brain insulin responsiveness using functional
        magnetic resonance imaging in combination with intranasal insulin in healthy participants of
        normal-weight and overweight/obesity. Two single endurance exercise sessions with different
        intensities will be evaluated, namely moderate intensity continuous training (MICT) and
        high-intensity interval training (HIIT). This will be compared to a waiting control
        condition. In a cross-over design, investigators will compare cerebral response from before
        to after intranasal insulin administration after a single bout of HIIT or MICT compared to a
        control condition without exercise. Cerebral response is defined as the cerebral blood flow
        and resting state functional connectivity in response to intranasal insulin. Secondary
        outcomes include changes in blood metabolites and proteins and changes in eating behavior.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Cerebral response after intranasal insulin administration
  time frame: 1 hour after exercise or waiting control
  description: The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
  measure: Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
  time frame: 1 hour after exercise or waiting control
  description: Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
  measure: Subjective feeling of hunger and food craving
  time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
  description: Questionnaire assessment before and after exercise or waiting control.
  measure: Changes in Blood-brain barrier integrity
  time frame: 1 hour after exercise or waiting control
  description: Robust multiple echo-time arterial spin labelling based Blood Brain Barrier integrity measurements from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
  measure: Performance during cognitive tasks
  time frame: 1 hour after exercise or waiting control
  description: Cambridge Cognition Tests Battery to assess memory and inhibitory control using the paired associates learning task, the pattern recognition memory task and the stop-signal reaction task.
  measure: Changes in exerkines from plasma samples
  time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
  description: Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
  measure: Change in incretins from plasma samples
  time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
  description: Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
  arm group label: moderate intensity continuous training
  arm group type: Experimental
  arm group label: High-intensity interval training
  arm group type: Experimental
  arm group label: Waiting condition
  arm group type: Placebo Comparator
  intervention type: Behavioral
  intervention name: single bout of moderate intensity continuous training (MICT)
  description: the MICT consists of 60 min continuous cycling
  arm group label: moderate intensity continuous training
  intervention type: Behavioral
  intervention name: single bout of High Intensity Interval Training (HIIT)
  description: HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover
  arm group label: High-intensity interval training
  intervention type: Behavioral
  intervention name: waiting control
  description: sitting in a waiting room for 60 min
  arm group label: Waiting condition
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andreas L. Birkenfeld, MD
  role: Study Director
  affiliation: Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
  last name: Stephanie Kullmann, PhD
  phone: 0049707129
  phone ext: 87703
  email: stephanie.kullmann@med.uni-tuebingen.de
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Insulin Resistance