<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/NCT03823664</url>
  </required_header>
  <id_info>
    <org_study_id>GO 17/793</org_study_id>
    <nct_id>NCT03823664</nct_id>
  </id_info>
  <brief_title>Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals</brief_title>
  <official_title>Assesment of Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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 aim of this study to investigate and compare cardiorespiratory fitness (CRF) parameters&#xD;
      of prediabetic, type 2 diabetic and healthy individuals. CRF assessed with cardiopulmonary&#xD;
      exercise test (CPET) which is gold standard measure of CRF. Pulmonary functions,&#xD;
      inflammation, disease specific parameters such as HbA1c, fasting plasma glucose etc affect&#xD;
      CRF in prediabetic and type 2 diabetics.All parameters examine in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be participated with Type 2 diabetic,prediabetic and healthy patients.&#xD;
      Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise&#xD;
      capacity, physical activity level, quality of life, cardiorespiratory fitness levels will&#xD;
      assess and record. Pulmonary function test will be assesed with CPET system, respiratory&#xD;
      muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated&#xD;
      using six minute walking test, incremental shuttle walk test. And cardiorespiratory fitness&#xD;
      will assess CPET system. Physical activity level will be evaluated trial accelerometer and&#xD;
      International Physical Activity Questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>November 2018-August 2019</time_frame>
    <description>Refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical exercise. It will be evaluated with Cardiopulmonary Exercise Test (CPET,CPX) System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Exercise Capacity</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>6 Minutes Walk Test's distance, meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functions</measure>
    <time_frame>December 2018-August 209</time_frame>
    <description>Forced expiratory volume in first second (FEV1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Muscle Strength</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>Mouth pressures; maximal inspiratory and expiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal Exercise Capacity</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>İncremental Shuttle Walk Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functions</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>Forced vital capacity (FVC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functions</measure>
    <time_frame>December 2018-August 2019</time_frame>
    <description>Peak expiratory flow (PEF)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Prediabetic State</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Cardiorespiratory Fitness</condition>
  <condition>Inflammation</condition>
  <condition>Exercise Test</condition>
  <arm_group>
    <arm_group_label>Type 2 Diabetic</arm_group_label>
    <description>Fasting Plasma Glucose ≥126 mg/dL (7.0 mmol/L). OR * A1C ≥6.5% (48 mmol/mol). OR * Patients with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).OR* 2-h Plasma Glucose ≥200 mg/dL (11.1 mmol/L) during oral glucose tolerance test*&#xD;
* American Diabetes As. (ADA) type 2 diabetes diagnosis criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prediabetic</arm_group_label>
    <description>Fasting Plasma Glucose 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (Impaired Fasting Glucose)* OR A1C 5.7-6.4% (39-47 mmol/mol)* OR 2-h Plasma Glucose during 75-g Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (Impaired Glucose Tolerance)*&#xD;
* ADA prediabetes criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Healthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiorespiratory Fitness</intervention_name>
    <description>Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Prediabetic</arm_group_label>
    <arm_group_label>Type 2 Diabetic</arm_group_label>
    <other_name>Exercise capacity</other_name>
    <other_name>Pulmonary function</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Type 2 diabetic patients -&gt; Type 2 diabetes diagnosed population, Prediabetic -&gt; According&#xD;
        to ADA criteria persons in prediabetic condition Healthy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cooperation,&#xD;
&#xD;
          -  No assistance for Ambulation,&#xD;
&#xD;
          -  Body Mass Index&lt;40&#xD;
&#xD;
          -  Diagnose of prediabetes/type 2 diabetes and health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cardiac problems,&#xD;
&#xD;
          -  Uncontrolled hypertension,&#xD;
&#xD;
          -  Any neurologic disease,&#xD;
&#xD;
          -  Uncontrolled diabetes,&#xD;
&#xD;
          -  Any orthopedic disease impairs walking, balance&#xD;
&#xD;
          -  Any respiratory disease affects cardiorespiratory fitness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru Calik-Kutukcu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hulya Arikan, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cemile Bozdemir-Ozel, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Selcuk Dagdelen, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Beyza Nur Karaduz, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Beyza Karadüz</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>prediabetes</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>cardiorespiratory fitness</keyword>
  <keyword>pulmonary functions</keyword>
  <keyword>functional capacity</keyword>
  <keyword>exercise capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03823664
org study id: GO 17/793
nct id: NCT03823664
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study to investigate and compare cardiorespiratory fitness (CRF) parameters
      of prediabetic, type 2 diabetic and healthy individuals. CRF assessed with cardiopulmonary
      exercise test (CPET) which is gold standard measure of CRF. Pulmonary functions,
      inflammation, disease specific parameters such as HbA1c, fasting plasma glucose etc affect
      CRF in prediabetic and type 2 diabetics.All parameters examine in this study.
This study will be participated with Type 2 diabetic,prediabetic and healthy patients.
      Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise
      capacity, physical activity level, quality of life, cardiorespiratory fitness levels will
      assess and record. Pulmonary function test will be assesed with CPET system, respiratory
      muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated
      using six minute walking test, incremental shuttle walk test. And cardiorespiratory fitness
      will assess CPET system. Physical activity level will be evaluated trial accelerometer and
      International Physical Activity Questionnaire.
observational model: Other
time perspective: Cross-Sectional
measure: Cardiorespiratory fitness
time frame: November 2018-August 2019
description: Refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical exercise. It will be evaluated with Cardiopulmonary Exercise Test (CPET,CPX) System
measure: Functional Exercise Capacity
time frame: December 2018-August 2019
description: 6 Minutes Walk Test's distance, meters
measure: Pulmonary functions
time frame: December 2018-August 209
description: Forced expiratory volume in first second (FEV1)
measure: Respiratory Muscle Strength
time frame: December 2018-August 2019
description: Mouth pressures; maximal inspiratory and expiratory pressure
measure: Maximal Exercise Capacity
time frame: December 2018-August 2019
description: İncremental Shuttle Walk Test
measure: Physical Activity Level
time frame: December 2018-August 2019
description: Accelerometer
measure: Pulmonary functions
time frame: December 2018-August 2019
description: Forced vital capacity (FVC)
measure: Pulmonary functions
time frame: December 2018-August 2019
description: Peak expiratory flow (PEF)
arm group label: Type 2 Diabetic
description: Fasting Plasma Glucose ≥126 mg/dL (7.0 mmol/L). OR * A1C ≥6.5% (48 mmol/mol). OR * Patients with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).OR* 2-h Plasma Glucose ≥200 mg/dL (11.1 mmol/L) during oral glucose tolerance test*
* American Diabetes As. (ADA) type 2 diabetes diagnosis criteria
arm group label: Prediabetic
description: Fasting Plasma Glucose 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (Impaired Fasting Glucose)* OR A1C 5.7-6.4% (39-47 mmol/mol)* OR 2-h Plasma Glucose during 75-g Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (Impaired Glucose Tolerance)*
* ADA prediabetes criteria
arm group label: Healthy
description: Healthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study.
intervention type: Diagnostic Test
intervention name: Cardiorespiratory Fitness
description: Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.
arm group label: Healthy
arm group label: Prediabetic
arm group label: Type 2 Diabetic
other name: Exercise capacity
other name: Pulmonary function
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ebru Calik-Kutukcu, PhD
role: Study Director
affiliation: Hacettepe University
last name: Hulya Arikan, Professor
role: Study Chair
affiliation: Hacettepe University
last name: Cemile Bozdemir-Ozel, MsC
role: Study Chair
affiliation: Hacettepe University
last name: Selcuk Dagdelen, Professor
role: Study Chair
affiliation: Hacettepe University
last name: Beyza Nur Karaduz, PT
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Beyza Karadüz
investigator title: Physiotherapist
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Inflammation
sharing ipd: Undecided