<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/NCT04503408</url>
  </required_header>
  <id_info>
    <org_study_id>GO19/704</org_study_id>
    <nct_id>NCT04503408</nct_id>
  </id_info>
  <brief_title>A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.</brief_title>
  <official_title>A Comparison of Pulmonary Function, Functional Capacity, Muscle Strength, Physical Activity, Physical Fitness and Activities of Daily Living in Cystic Fibrosis Patient's With and Without Abnormal Glucose Tolerance.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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>
      Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis&#xD;
      transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population.&#xD;
      CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid&#xD;
      ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems&#xD;
      such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed.&#xD;
      This study aims comparison between lung function, functional capacity, muscle strength,&#xD;
      physical activity, physical fitness and activities of daily living activities in cystic&#xD;
      fibrosis with and without abnormal glucose tolerance&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aimed that comparison of clinical parameters in children with and without abnormal&#xD;
      glucose tolerance in Cystic fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2019</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Distance of 6 minute walk test</measure>
    <time_frame>28 week</time_frame>
    <description>Distance of 6 minute walk test assesing functional capacity made on flat corridor with speed is determined from participant. She/he walks during 6 minute on this corridor as quickly as possible.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung function</measure>
    <time_frame>28 week</time_frame>
    <description>Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>28 week</time_frame>
    <description>Both inspiratory and expiratory muscle strength wil be evaluated at least three times in Cystic fibrosis. Mouth pressure device will be used for evaluate. The highest value for MIP and MEP will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadriceps muscle strength</measure>
    <time_frame>28 week</time_frame>
    <description>Quadriceps muscle strength will be assessed least three times in children with cystic fibrosis. hand held dynamometer will be used for assessing quadriceps muscle strength. The highest value for each side will be recorded and used for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Handgrip</measure>
    <time_frame>28 week</time_frame>
    <description>Handgrip will be assessed in Cystic fibrosis using hand dynamometer (Jamar hand dynamometer). Assessing will be repeated three times end mean of three measurement will be calculated and used for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>28 week</time_frame>
    <description>Physical activity will be evaluated with Bouchard physical activity record. This activity recorder is evaluated every 15 min in a day. Two weekday and one weekend day are recorded with made activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical fitness</measure>
    <time_frame>28 week</time_frame>
    <description>Physical fitness is measured with Munich physical fitness test battery. This battery vertial jump, bouncing ball, flexibilty, climbing, throwing bag, step up test are included in battery. the battery evaluates such as strength, endurance, speed, flexibilty, coordination, power.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance of shuttle walk test</measure>
    <time_frame>28 week</time_frame>
    <description>Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of activities of daily living test</measure>
    <time_frame>28 week</time_frame>
    <description>Activities of daily living will be tested with the Glittre ADL test. This test includes five repeated cycles that includes sitting, walk, step up and changing place of object on bookshelf in test procedure. The total completion time of five cycles will be recorded and used for analysis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Cystic Fibrosis-related Diabetes</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>cystic fibrosis with abnormal glucose tolerance</arm_group_label>
    <description>cystic fibrosis with abnormal glucose tolerance Cystic fibrosis patients with descripted that impaired glucose tolerance or cystic fibrosis related diabetes by oral glucose tolerance test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cystic fibrosis with normal glucose tolerance</arm_group_label>
    <description>cystic fibrosis with normal glucose tolerance Cystic fibrosis patients with descripted that normal glucose tolerance by oral glucose tolerance test</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and&#xD;
        without abnormal glucose tolerance&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes&#xD;
             for Abnormal glucose tolerance group&#xD;
&#xD;
          2. Cooperation for tests&#xD;
&#xD;
          3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems&#xD;
             that effecting tests,&#xD;
&#xD;
          4. To volunteer for the study.&#xD;
&#xD;
        For the control group&#xD;
&#xD;
          1. Cystic fibrosis with normal glucose tolerance&#xD;
&#xD;
          2. Cooperation for tests&#xD;
&#xD;
          3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems&#xD;
             that effecting tests,&#xD;
&#xD;
          4. To volunteer for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients having following disease&#xD;
&#xD;
          1. Acute pulmonary exacerbation&#xD;
&#xD;
          2. Acute or chronic respiratory failure&#xD;
&#xD;
          3. FEV₁ lower than %40&#xD;
&#xD;
          4. Cooperation problems,&#xD;
&#xD;
          5. Bronchopulmonary aspergillus and using steroid.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Elif Kocaaga</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>April 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Elif Kocaaga</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Glucose</keyword>
  <keyword>Cystic fibrosis</keyword>
  <keyword>Muscle strength</keyword>
  <keyword>Physical fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Fibrosis</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/NCT04503408
org study id: GO19/704
nct id: NCT04503408
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis
      transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population.
      CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid
      ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems
      such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed.
      This study aims comparison between lung function, functional capacity, muscle strength,
      physical activity, physical fitness and activities of daily living activities in cystic
      fibrosis with and without abnormal glucose tolerance
The study aimed that comparison of clinical parameters in children with and without abnormal
      glucose tolerance in Cystic fibrosis.
observational model: Other
time perspective: Prospective
measure: Distance of 6 minute walk test
time frame: 28 week
description: Distance of 6 minute walk test assesing functional capacity made on flat corridor with speed is determined from participant. She/he walks during 6 minute on this corridor as quickly as possible.
measure: Lung function
time frame: 28 week
description: Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.
measure: Respiratory muscle strength
time frame: 28 week
description: Both inspiratory and expiratory muscle strength wil be evaluated at least three times in Cystic fibrosis. Mouth pressure device will be used for evaluate. The highest value for MIP and MEP will be recorded.
measure: Quadriceps muscle strength
time frame: 28 week
description: Quadriceps muscle strength will be assessed least three times in children with cystic fibrosis. hand held dynamometer will be used for assessing quadriceps muscle strength. The highest value for each side will be recorded and used for analysis.
measure: Handgrip
time frame: 28 week
description: Handgrip will be assessed in Cystic fibrosis using hand dynamometer (Jamar hand dynamometer). Assessing will be repeated three times end mean of three measurement will be calculated and used for analysis.
measure: Physical activity levels
time frame: 28 week
description: Physical activity will be evaluated with Bouchard physical activity record. This activity recorder is evaluated every 15 min in a day. Two weekday and one weekend day are recorded with made activity.
measure: Physical fitness
time frame: 28 week
description: Physical fitness is measured with Munich physical fitness test battery. This battery vertial jump, bouncing ball, flexibilty, climbing, throwing bag, step up test are included in battery. the battery evaluates such as strength, endurance, speed, flexibilty, coordination, power.
measure: Distance of shuttle walk test
time frame: 28 week
description: Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.
measure: Time of activities of daily living test
time frame: 28 week
description: Activities of daily living will be tested with the Glittre ADL test. This test includes five repeated cycles that includes sitting, walk, step up and changing place of object on bookshelf in test procedure. The total completion time of five cycles will be recorded and used for analysis
arm group label: cystic fibrosis with abnormal glucose tolerance
description: cystic fibrosis with abnormal glucose tolerance Cystic fibrosis patients with descripted that impaired glucose tolerance or cystic fibrosis related diabetes by oral glucose tolerance test
arm group label: cystic fibrosis with normal glucose tolerance
description: cystic fibrosis with normal glucose tolerance Cystic fibrosis patients with descripted that normal glucose tolerance by oral glucose tolerance test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Elif Kocaaga
investigator title: Principal investigator
mesh term: Cystic Fibrosis
mesh term: Diabetes Mellitus
mesh term: Fibrosis