<?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>IRCT20181002041204N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-25</date_registration>
      <primary_sponsor>Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>Effect of exercise on type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of concurrent training order on some mitochondrial, ribosome biogenesis regulatory myokines and insulin resistance in type 2 diabetes patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37511</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Restricted randomization (random allocation rule) with using the SAS software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: The aerobic-resistance group will exercise for 12 weeks and three sessions a week. The aerobic-resistance group will perform the aerobic protocol and then the resistance protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine. Intervention 2: The second intervention group: The resistance-aerobic group will exercise for 12 weeks and three sessions a week. The resistance-aerobic group will perform the resistance protocol and then the aerobic protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine. Intervention 3: Control group: community-based and untrained.</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 whole data is potentially shared after unidentified individuals.

When:
The beginning of the data access period is 6 months after the publication of the articles.

To whom:
The data will be accessible only to researchers working in academic institutions.

Conditions:
The data will be available as generally and non publication by the recipient.

Where to obtain:
To receive research information, send an email to Reihane.nejati@gmail.com.

How to obtain:
Data will be sent after obtaining permission from the project manager.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Bijeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sport Sciences, Ferdowsi University of Mashhad, Azadi square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 5403</telephone>
        <email>bijeh@um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Bijeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sport Sciences, Ferdowsi University of Mashhad, Azadi square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 5403</telephone>
        <email>bijeh@um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of Type 2 Diabetes (Fasting blood glucose greater than 126 mg/dL, Oral glucose tolerance test equal to or greater than 200 mg/dL, A1C level of 6.5 percent or higher)
BMI 28-35
Age between 40-50 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>use insulin
having  cardiovascular diseases, musculoskeletal disorders, liver disease, kidney disease, thyroid dysfunction
having regular physical activity in at least the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: The aerobic-resistance group will exercise for 12 weeks and three sessions a week. The aerobic-resistance group will perform the aerobic protocol and then the resistance protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine.</i_keyword>
      <i_keyword>The second intervention group: The resistance-aerobic group will exercise for 12 weeks and three sessions a week. The resistance-aerobic group will perform the resistance protocol and then the aerobic protocol during a training session. The aerobic exercise protocol is 1×10 minutes exercise with one minute active rest between the sets (with using treadmill). Resistance exercises include movements such as leg press, bench press, seated leg extension, lat pull down, lying leg curl, seated shoulder press, which there are include the main muscles of the lower trunk and upper trunk and they will be done by the machine.</i_keyword>
      <i_keyword>Control group: community-based and untrained.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myostatin (MSTN). Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Follistatin (FSTL). Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Fibroblast Growth Factor 21 (FGF21). Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: HOMA-IR method.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before the intervention and 48 hours after the end of intervention. Method of measurement: Nyco Card device.</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>Ferdowsi University of Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-10</approval_date>
        <contact_name>Ethics committee of Ferdowsi University of Mashhad</contact_name>
        <contact_address>Ferdowsi University of Mashhad, Azadi square. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-22</approval_date>
        <contact_name>Ethics committee Mahshad University of Medical Sciences</contact_name>
        <contact_address>Mahshad University of Medical Sciences, Azadi square. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
