<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/NCT04450745</url>
  </required_header>
  <id_info>
    <org_study_id>Hypoxia-DiabetesT1</org_study_id>
    <nct_id>NCT04450745</nct_id>
  </id_info>
  <brief_title>Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients</brief_title>
  <official_title>Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silesian Centre for Heart Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Jerzy Kukuczka Academy of Physical Education in Katowice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Silesian Centre for Heart Diseases</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>
      Physical activity, along with proper nutrition, is the basis for the behavioral treatment of&#xD;
      diabetes. In recent years exercise training in normobaric hypoxia is used in training&#xD;
      programs for athletes and in rehabilitation. The aim of this study is the assessment of&#xD;
      physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood&#xD;
      glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and&#xD;
      time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric&#xD;
      parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of&#xD;
      many genes (eg. gene responsible for erythropoetin production). It also stimulates&#xD;
      angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes&#xD;
      involved in extracellular glucose import.&#xD;
&#xD;
      Before starting the training program all participants will be assessed by cardiologist. Then&#xD;
      the incremental exercise test will be performed to determine aerobic capacity (VO2max).&#xD;
&#xD;
      Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in&#xD;
      normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an&#xD;
      altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).&#xD;
&#xD;
      Training program will be the same for all participants: 60 minutes sessions twice a week for&#xD;
      6 weeks of mixed exercise: aerobic and anaerobic.&#xD;
&#xD;
      Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same&#xD;
      glucometer model by all patients.&#xD;
&#xD;
      At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and&#xD;
      blood pressure monitoring, lipid profile and diabetes control parameters will be performed in&#xD;
      all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum oxygen consumption (VO2max)</measure>
    <time_frame>6 weeks</time_frame>
    <description>measured during Incremental exercise test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic control of diabetes</measure>
    <time_frame>6 weeks</time_frame>
    <description>HbA1c (%,mmol/mol)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose stability</measure>
    <time_frame>6 weeks</time_frame>
    <description>Time In Range (TIR, %) while using Continous Glucose Monitoring System</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>type1diabetes</condition>
  <arm_group>
    <arm_group_label>Exercise in hypoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will have training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above see level( indoor air composition: 15,4% of O2 and 84,7% of N)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise in normoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will have the same training program in normoxic conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise in hypoxia</intervention_name>
    <description>60 minutes training program of mixed exercise in normobaric hypoxic chamber</description>
    <arm_group_label>Exercise in hypoxia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise in normoxia</intervention_name>
    <description>60 minutes training program of mixed exercise in regular air conditions</description>
    <arm_group_label>Exercise in normoxia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes of at least 10 years duration&#xD;
&#xD;
          -  low physical activity&#xD;
&#xD;
          -  BMI 20-30 kg/m2&#xD;
&#xD;
          -  treated with multiple insulin injections (at least 4) or insulin pump (continuous&#xD;
             subcutaneous insulin infusion [CSII])&#xD;
&#xD;
          -  negative ECG exercise test&#xD;
&#xD;
          -  HbA1c ≤ 8,0%&#xD;
&#xD;
          -  high knowledge about functional insulin therapy, carbohydrate counting and diabetes&#xD;
             management during exercise&#xD;
&#xD;
          -  use of advanced glucometer functions and experience in use of Free Style Libre (Flash&#xD;
             Glucose Monitoring System, Abbott)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HbA1c &gt; 8,0%,&#xD;
&#xD;
          -  advanced complications of diabetes [pre-proliferative or proliferative retinopathy,&#xD;
             and previous laser therapy, microalbuminuria or overt nephropathy, autonomic&#xD;
             neuropathy (including lack of elevated heart rate during physical activity)]&#xD;
&#xD;
          -  patients physically active (regular physical activities more than once a week),&#xD;
&#xD;
          -  positive ECG exercise test, history of cardiovascular event or coronary heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krzysztof Strojek, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marta Wróbel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland</name>
      <address>
        <city>Zabrze</city>
        <state>Silesia</state>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT04450745
org study id: Hypoxia-DiabetesT1
nct id: NCT04450745
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical activity, along with proper nutrition, is the basis for the behavioral treatment of
      diabetes. In recent years exercise training in normobaric hypoxia is used in training
      programs for athletes and in rehabilitation. The aim of this study is the assessment of
      physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood
      glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and
      time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric
      parameters.
Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of
      many genes (eg. gene responsible for erythropoetin production). It also stimulates
      angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes
      involved in extracellular glucose import.

      Before starting the training program all participants will be assessed by cardiologist. Then
      the incremental exercise test will be performed to determine aerobic capacity (VO2max).

      Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in
      normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an
      altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).

      Training program will be the same for all participants: 60 minutes sessions twice a week for
      6 weeks of mixed exercise: aerobic and anaerobic.

      Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same
      glucometer model by all patients.

      At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and
      blood pressure monitoring, lipid profile and diabetes control parameters will be performed in
      all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum oxygen consumption (VO2max)
time frame: 6 weeks
description: measured during Incremental exercise test
measure: Metabolic control of diabetes
time frame: 6 weeks
description: HbA1c (%,mmol/mol)
measure: Glucose stability
time frame: 6 weeks
description: Time In Range (TIR, %) while using Continous Glucose Monitoring System
arm group label: Exercise in hypoxia
arm group type: Experimental
description: Patients randomized to this arm will have training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above see level( indoor air composition: 15,4% of O2 and 84,7% of N)
arm group label: Exercise in normoxia
arm group type: Experimental
description: Patients randomized to this arm will have the same training program in normoxic conditions
intervention type: Behavioral
intervention name: Exercise in hypoxia
description: 60 minutes training program of mixed exercise in normobaric hypoxic chamber
arm group label: Exercise in hypoxia
intervention type: Behavioral
intervention name: Exercise in normoxia
description: 60 minutes training program of mixed exercise in regular air conditions
arm group label: Exercise in normoxia
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: No
last name: Krzysztof Strojek, Professor
role: Study Chair
affiliation: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
last name: Marta Wróbel, PhD
role: Principal Investigator
affiliation: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Hypoxia