<?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>IRCT2015100423002N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-04</date_registration>
      <primary_sponsor>Vice president of of Research of Tehran University</primary_sponsor>
      <public_title>Effect of exercise training on endothelial function of type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of differential exercise training on endothelial function of type 2 diabetes and relation with inflammatory cytokines</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19737</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization work by randomizing participants within blocks such that an equal number are assigned to each intervention groups. Given a block size in this study was 4 assign participants to a block, Blinding description: The participants were aware of the study. However, they did not know assigned to which groups, because 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 2diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: High- volume high- intensity interval training that consists of 6 intervals 4 minutes at 85- 90% HRmax which separated by 3 minutes at 45-50% HRmax. Intervention 2: Intervention group 2: 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. Intervention 3: Intervention group3: continuous moderate intensity training consists of 42 minutes at 70% HRmax. Intervention 4: 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Ghardashi Afousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439956141</zip>
        <telephone>+98 21 8201 5031</telephone>
        <email>Ghardashi.a@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Ghardashi Afousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Science, above the intersection Jalal Al-e Ahmad, North Kargar Avenue, Islamic Revolution Square.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439956141</zip>
        <telephone>+98 21 8201 5031</telephone>
        <email>Ghardashi.a@ut.ac.ir</email>
        <affiliation>University of Tehran</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 &lt;6%(HbA1C &lt;6%)
Body mass index over 25
Hypertension uncontrolled pre 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 &lt; 170/100 mmHg)
Insulin therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E 11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: High- volume high- intensity interval training that consists of 6 intervals 4 minutes at 85- 90% HRmax which separated by 3 minutes at 45-50% HRmax.</i_keyword>
      <i_keyword>Intervention group 2: 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.</i_keyword>
      <i_keyword>Intervention group3: continuous moderate intensity training consists of 42 minutes at 70% HRmax.</i_keyword>
      <i_keyword>Control group: normal condition without any exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nitrite/Nitrate plasma. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Endothelin-1. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Flow mediated dilation. Timepoint: Before and after 12 week intervention. Method of measurement: Ultrasound doppler.</prim_outcome>
      <prim_outcome>Carotid intima-media thickness. Timepoint: Before and after 12 week intervention. Method of measurement: Ultrasound doppler.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before and after 12 week intervention. Method of measurement: HOMA-IR.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Before and after 12 week intervention. Method of measurement: Enzymatic.</prim_outcome>
      <prim_outcome>Applin. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Peak consumption oxygen. Timepoint: Before and after 12 week intervention. Method of measurement: Gas analyser system.</prim_outcome>
      <prim_outcome>Diastolic and systolic blood pressure. Timepoint: Before and after 12 week intervention. Method of measurement: oscillometric device.</prim_outcome>
      <prim_outcome>Heart rate rest. Timepoint: Before and after 12 week intervention. Method of measurement: Cornometer/ numbere.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before and after 12 week intervention. Method of measurement: Enzymatic.</prim_outcome>
      <prim_outcome>Malondealdehid. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Glutathion proxidase. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after 12 week intervention. Method of measurement: ELISA kit.</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>Vice president of of Research of Tehran University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-31</approval_date>
        <contact_name>Ethics committee of University of Tehran</contact_name>
        <contact_address>16th Azar Street, Enghelab Square, Central Organization of University of Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
