<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/NCT01727661</url>
  </required_header>
  <id_info>
    <org_study_id>201201005RIC</org_study_id>
    <nct_id>NCT01727661</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM</brief_title>
  <official_title>Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the differences of&#xD;
&#xD;
        1. cardiopulmonary fitness&#xD;
&#xD;
        2. lung function&#xD;
&#xD;
        3. muscular oxygen saturation&#xD;
&#xD;
        4. quality of life between type 1 diabetes mellitus and healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is also to investigate the relationships between cardiopulmonary fitness, lung&#xD;
      function, muscular oxygen saturation, glycemic control, and quality of life in patients with&#xD;
      type 1 diabetes mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>exercise testing with near-infrared spectroscopy</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>lung function</measure>
    <time_frame>at baseline</time_frame>
    <description>flow volume loop, lung diffusing capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at baseline</time_frame>
    <description>short-forum 36</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>type 1 diabetes mellitus</arm_group_label>
    <description>exercise testing with near-infrared spectroscopy&#xD;
lung function testing&#xD;
quality of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>exercise testing with near-infrared spectroscopy&#xD;
lung function testing&#xD;
quality of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exercise testing with near-infrared spectroscopy</intervention_name>
    <description>subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.</description>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>type 1 diabetes mellitus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lung function testing</intervention_name>
    <description>spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation.&#xD;
single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.</description>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>type 1 diabetes mellitus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>quality of life</intervention_name>
    <description>assessing quality of life using short-forum 36 (questionnaire)</description>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>type 1 diabetes mellitus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        outpatient department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)&#xD;
&#xD;
          -  age-, gender-, and BMI-matched healthy subjects (control group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac or respiratory disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  hospitalization due to any medical condition in recent 6 months&#xD;
&#xD;
          -  any other condition affecting exercise performance or lung function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying-Tai Wu, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Wanke T, Formanek D, Auinger M, Zwick H, Irsigler K. Pulmonary gas exchange and oxygen uptake during exercise in patients with type 1 diabetes mellitus. Diabet Med. 1992 Apr;9(3):252-7. doi: 10.1111/j.1464-5491.1992.tb01771.x.</citation>
    <PMID>1576807</PMID>
  </reference>
  <reference>
    <citation>Komatsu WR, Barros Neto TL, Chacra AR, Dib SA. Aerobic exercise capacity and pulmonary function in athletes with and without type 1 diabetes. Diabetes Care. 2010 Dec;33(12):2555-7. doi: 10.2337/dc10-0769. Epub 2010 Aug 31.</citation>
    <PMID>20807874</PMID>
  </reference>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>July 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 6, 2013</last_update_submitted>
  <last_update_submitted_qc>March 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes mellitus</keyword>
  <keyword>cardiopulmonary fitness</keyword>
  <keyword>lung function</keyword>
  <keyword>muscular oxygenation</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>
  <!-- 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/NCT01727661
org study id: 201201005RIC
nct id: NCT01727661
lead sponsor: 
has dmc: No
The purpose of this study is to compare the differences of

        1. cardiopulmonary fitness

        2. lung function

        3. muscular oxygen saturation

        4. quality of life between type 1 diabetes mellitus and healthy adults.
This study is also to investigate the relationships between cardiopulmonary fitness, lung
      function, muscular oxygen saturation, glycemic control, and quality of life in patients with
      type 1 diabetes mellitus.
observational model: Case-Control
time perspective: Cross-Sectional
measure: exercise testing with near-infrared spectroscopy
time frame: at baseline
measure: lung function
time frame: at baseline
description: flow volume loop, lung diffusing capacity
measure: quality of life
time frame: at baseline
description: short-forum 36
arm group label: type 1 diabetes mellitus
description: exercise testing with near-infrared spectroscopy
lung function testing
quality of life
arm group label: healthy controls
description: exercise testing with near-infrared spectroscopy
lung function testing
quality of life
intervention type: Behavioral
intervention name: exercise testing with near-infrared spectroscopy
description: subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.
arm group label: healthy controls
arm group label: type 1 diabetes mellitus
intervention type: Behavioral
intervention name: lung function testing
description: spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation.
single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.
arm group label: healthy controls
arm group label: type 1 diabetes mellitus
intervention type: Behavioral
intervention name: quality of life
description: assessing quality of life using short-forum 36 (questionnaire)
arm group label: healthy controls
arm group label: type 1 diabetes mellitus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ying-Tai Wu, phD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
citation: Wanke T, Formanek D, Auinger M, Zwick H, Irsigler K. Pulmonary gas exchange and oxygen uptake during exercise in patients with type 1 diabetes mellitus. Diabet Med. 1992 Apr;9(3):252-7. doi: 10.1111/j.1464-5491.1992.tb01771.x.
PMID: 1576807
citation: Komatsu WR, Barros Neto TL, Chacra AR, Dib SA. Aerobic exercise capacity and pulmonary function in athletes with and without type 1 diabetes. Diabetes Care. 2010 Dec;33(12):2555-7. doi: 10.2337/dc10-0769. Epub 2010 Aug 31.
PMID: 20807874
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1