<?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>IRCT20181129041797N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-25</date_registration>
      <primary_sponsor>Shahid Rajaee Cardiovascular Research and Treatment Center</primary_sponsor>
      <public_title>The effect of two types of aerobic exercise on inflammatory factors in type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparisons effect of eight weeks high intensity interval training (HIIT) and continuous moderate training (CMT) on plasma levels of Calprotectin and IL-6 in type 2 diabetic persons</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35598</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization tool: such as random numbered table, Sealed envelope, statistical software, Blinding description: This study is done triple blind and the only researcher knows how to assign individuals to different groups.In general, all participants in this project are unaware of what kind of sports group they are said to be, and the researcher will individually give the exercises to individuals and will not be explained to people about the type and name of the exercise. Only the type of  exercises that are aerobic on a treadmill will be provided to individuals. In fact, the data analyst, clinical caregiver, outcome assessor, as well as the safety committee and data monitoring will not know how to assign exercises.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:High intensity interval training that performs interval aerobic training for 8 weeks and 3 sessions per week. Intervention 2: Intervention group 2: Continuous moderate training that will performs continuous aerobic exercise for 8 weeks and 3 sessions a week. Intervention 3: Control group: The control group is not given any training.</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:
In this study, the personal information of the participants in the project, such as age range, height range, weight range, BMI range,  will be published as a table. Also, upon completion of the protocol, the result of the effect of the  protocol on the specified factors, Insulin resistance and  HA1c will also be published.

When:
Access time since 1398

To whom:
All participants in this project can be informed on request if they so request. Also, all diabetics at the Shahid Rajaee Cardiology and Heart Disease Hospital, Tehran University of Medical Sciences and Semnan University can access the results of this project. Researchers at different universities.People who working in hospital rehab centers.It is important to point that people outside the project, at academic levels with the reason for the request, can get results if they are interested.

Conditions:
Participants in the study and diabetics at Shahid Rajaee Hospital and Tehran University of Medical Sciences Diabetes Clinic To know how the protocols affect the conditions of their disease, they can inform the results and documentation so that they can be used if the protocols are useful. Researchers also access documents in order to use results in similar research. People working in rehab groups can also use documentation and protocols to perform protocols for diabetics.

Where to obtain:
People can submit their requests to the following email addresses:
mohsenavandi@gmail.com
Z.ghaemmaghami@rhc.ac.ir
rambod.camelia@gmail.com
s.alizadeh@semnan.ac.ir

How to obtain:
Applicants send an email with the subject of the request to the addresses provided. Upon receipt of the email, a form will be sent to them, specifying the individuals and the reason for their request will be recorded in this form after completing the form and re-submitting the form to The email documentation will be available as pdf files.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra ghaemmaghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaee Cardiovascular Research and Treatment Center,Intersection of Niayesh, Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 2392 2197</telephone>
        <email>Z.ghaemmaghami@rhc.ac.ir</email>
        <affiliation>Shahid Rajaee Cardiovascular Research and Treatment Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Avandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Organization of Semnan University,in front of the Sokan Park, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35131-19111</zip>
        <telephone>+98 23 3365 4100</telephone>
        <email>mohsenavandi@gmail.com</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes
Body mass is between 25 and 35 kg / m 2
Age range 35 to 60 years</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with cardiovascular disease
People who have kidney and liver problems
People with pulmonary disease
People who have gout or orthopedic restrictions
smokers
Alcoholics</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:High intensity interval training that performs interval aerobic training for 8 weeks and 3 sessions per week.</i_keyword>
      <i_keyword>Intervention group 2: Continuous moderate training that will performs continuous aerobic exercise for 8 weeks and 3 sessions a week</i_keyword>
      <i_keyword>Control group: The control group is not given any training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma levels of Calprotectin. Timepoint: Before starting the training protocols and 8 weeks later (after completing the practice protocols). Method of measurement: blood sampling.</prim_outcome>
      <prim_outcome>Plasma levels of IL-6. Timepoint: Before starting the training protocols and 8 weeks later (after completing the practice protocols). Method of measurement: blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Rajaee Cardiovascular Research and Treatment Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan university</source_name>
      <source_name>Shahid Rajaee Cardiovascular Research and Treatment Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-29</approval_date>
        <contact_name>Ethics Committee of the Shahid Rajaee Cardiology Research Center</contact_name>
        <contact_address>Shahid Rajaee Cardiology Research Center, Intersection of Niayesh, Valiasr street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
