<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200412047039N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-07</date_registration>
      <primary_sponsor>The University of Razi</primary_sponsor>
      <public_title>Effect of Interval Training on endothelial function</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 12-week aerobic interval training on endothelial function and serum levels of Adropin in type 2 diabetic women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The eligible participants were randomly divided into two groups: high-intensity interval training and control. Randomization was performed by block randomization with a block size of two (Based on age and body mass index).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: exercise training program performs three times a week for 12 weeks. Each exercise session consist of 10-min of warm up at 40% heart rate maximum(HRmax) and 25 minutes of running on treadmill, including four four-minute interval at 85-95% of HRmax and 3 minutes at 50-60% of HRmax and end with a 5 minutes cool down at 40% of HRmax. Intervention 2: Control group: No exercise intervention are performed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data of the participating participants will be encrypted and will be published with the privacy of the patient and the confidentiality of the information.

When:
The date of access to the data is six months after the publication of the results.

To whom:
Only available to scholars working in academic and academic institutions

Conditions:
The requirements for access to data include the sending of documents relating to the applicant's membership in academic and academic institutions, and the applicant is authorized to use this data in order to document for subsequent studies.

Where to obtain:
You can use the email address to access the information: shiva.abdi101@yahoo.com

How to obtain:
The applicant will send the data to him at least one month later by sending valid credentials to members of the academic and research institutes at the email address of the author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Directorate General of Kurdistan welfare, Shebli Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1111111111</zip>
        <telephone>+98 87 3366 3612</telephone>
        <email>shiva.abdi101@yahoo.com</email>
        <affiliation>The University of Razi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shiva Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Directorate General of Kurdistan Welfare, Shebli Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1111111111</zip>
        <telephone>+98 87 3366 3612</telephone>
        <email>shiva.abdi101@yahoo.com</email>
        <affiliation>The University of Razi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fasting blood glucose levels more than 125 mg/dL
Age range 20 to 44 years
More than 2 years history of type 2 diabetic
No exercise training in the previous 6 months before the  study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>HbA1c more than 10%
Insulin therapy
Having any chronic disease other than type 2 diabetic</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: exercise training program performs three times a week for 12 weeks. Each exercise session consist of 10-min of warm up at 40% heart rate maximum(HRmax) and 25 minutes of running on treadmill, including four four-minute interval at 85-95% of HRmax and 3 minutes at 50-60% of HRmax and end with a 5 minutes cool down at 40% of HRmax.</i_keyword>
      <i_keyword>Control group: No exercise intervention are performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Flow Mediated Dilation. Timepoint: Before and after 12 weeks exercise training. Method of measurement: Doppler ultrasound system.</prim_outcome>
      <prim_outcome>Serum adropin levels. Timepoint: Before and after 12 weeks exercise training. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Plasma nitrite/nitrate levels. Timepoint: Before and after 12 weeks exercise training. Method of measurement: Griess method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Glycosylated hemoglobin. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Chromatography method.</sec_outcome>
      <sec_outcome>Plasma insulin levels. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: ELISA method.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Weight in kilograms divided by height in meters squared.</sec_outcome>
      <sec_outcome>Waist-Hip ratio. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Body fat percentage. Timepoint: Before and after the 12 weeks exercise training. Method of measurement: Using Jackson-Pollock 3-spot formula by a Caliper.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Razi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-30</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Central building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
