<?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>IRCT20200810048351N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of interval and continuous training on endothelial function in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12-weeks of interval and continuous training on vaspin, Asymmetric dimethyl-arginine and relationship with flow-mediated dilation in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed by blocking based on gender and age which performed by www.randomizatoin.com. The A code was used for women and B for men. The block size was 3. We used a code for a rage of 10 years. The 1 code included participants that ages was between 40-50 years, 2 code included participants that ages was between 50-60 years and 3 code included participants that ages was between 60-70 years. Therefore, if a person with a male gender and age range was 40 to 50 years, he would be assigned according to the system with A1 code, and if a person with a female gender and age range of 40 to 50 years, she would be assigned with B1 code. According to the 2 sexes of men and women and 3 age groups, combination of 6 types of codes including A1, A2, A3, B1, B2, B3 were placed in one block. In the data entry section, the number of subjects, codes and block size were entered. The output consisted of 12 blocks of 6 people and a block of 3 people, which was provided to us in the form of a table by the site itself. Therefore, each group consisted of 4 blocks and one code, Blinding description: The participants were aware of the study. They were assigned in groups based on randomization and the codes. The evaluators are specialists who were unaware of the grouping and the purpose of the study. Statistical analysis was performed by statisticians who were unaware of the study because the groups were sent to him based on coding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax. Exercise training was performed 3 session per week for 12- weeks. Intervention 2: Intervention group 2: continuous moderate intensity training consists of 42 minutes at 70% HRmax. Exercise training was performed 3 session per week for 12- weeks. Intervention 3: Control group:  normal condition without any exercise.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is not decision.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>yazda.setayesh98@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahaz Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Lecture, Human and Social Science, Islamic Azad University, Science and Research Branch, Daneshgah Blvd, Simon Bolivar Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>yazdan.setayesh98@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of type 2 diabetes more than 2 years
No history of 6 months of regular exercise
Glycosylated hemoglobin above 6%(HbA1C &gt;6%)
Body mass index over 25
Pre hypertension or I stage</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>HbA1C over 10%
Fasting blood glucose more than 400 mg/dl
Functional limitations (such as osteoarthritis)
Liver and kidney disease
Myocardial infarction
Coronary artery bypass surgery or angioplasty
Chronic heart failure
Cardiac arrhythmia's
Smoking
Uncontrolled BP (BP &gt; 170/100 mmHg)
Insulin therapy</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax. Exercise training was performed 3 session per week for 12- weeks.</i_keyword>
      <i_keyword>Intervention group 2: continuous moderate intensity training consists of 42 minutes at 70% HRmax. Exercise training was performed 3 session per week for 12- weeks.</i_keyword>
      <i_keyword>Control group:  normal condition without any exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vaspin. Timepoint: Before and after 12-weeks intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Asymmetric dimethy-argenin. Timepoint: Before and after 12-weeks intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Nitrite/nitrate. Timepoint: Before and after 12-weeks intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Flow-mediated dilation. Timepoint: Before and after 12-weeks intervention. Method of measurement: Ultrasound doppler.</prim_outcome>
      <prim_outcome>Insuline resistance. Timepoint: Before and after 12-weeks. Method of measurement: HOMA-IR.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after 12-weeks intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Before and after 12-weeks intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Peak oxygen consumption. Timepoint: Before and after 12-week intervention. Method of measurement: Gas analyser system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-27</approval_date>
        <contact_name>Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
