<?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>IRCT20180721040542N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-15</date_registration>
      <primary_sponsor>Shahrood University of Technology</primary_sponsor>
      <public_title>The effect of endurance and resistance training on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 8 weeks of endurance and resistance training on  fibroblast growth factor 21 (FGF21) and insulin resistance in type 2 diabetic women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization is that people based on finger blood glucose are divided into three groups.
So that the average blood glucose in each group is similar.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>The endurance group performed aerobic exercises in the first two weeks for 20 minutes at 50% heart rate, and at 3rd and 4th weeks for 30 minutes with 50% heart rate, and fifth and sixth weeks for 30 minutes with 60% heart rate and In the last two weeks, they perform for 35 minutes with 60% heart rate. To determine the intensity of exercise, the maximum heart rate was calculated with the formula of 220 - age.                                     Resilience group performed at the first session of resistance training for proper learning of movements, subjects with minimum weight and several sub-maximal repetitions Then, resistance exercises were performed using bodybuilding machines in the first and second weeks in two sets, from the third week to the end The course is carried out in three sets with a intensity of 75% one maximum repetition..</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahbobe Khorsand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Units2, number5, Khordad1 avenue</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96719-98144</zip>
        <telephone>+98 51 5525 8277</telephone>
        <email>mahbobekhorsand@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahbobe Khorsand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Units2, number5, Khordad1 avenue</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96719-98144</zip>
        <telephone>+98 51 5525 8277</telephone>
        <email>mahbobekhorsand@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>According to a physician's diagnosis, they have more than one year of type 2 Diabetes
Have a low mobility
Use only Glucose-lowering drugs (Metformin)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have be Secondary complications of diabetes, such as ocular, kidney complications
Have be cardiovascular and inflammatory diseases
Have a physical injury</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The endurance group performed aerobic exercises in the first two weeks for 20 minutes at 50% heart rate, and at 3rd and 4th weeks for 30 minutes with 50% heart rate, and fifth and sixth weeks for 30 minutes with 60% heart rate and In the last two weeks, they perform for 35 minutes with 60% heart rate. To determine the intensity of exercise, the maximum heart rate was calculated with the formula of 220 - age.                                     Resilience group performed at the first session of resistance training for proper learning of movements, subjects with minimum weight and several sub-maximal repetitions Then, resistance exercises were performed using bodybuilding machines in the first and second weeks in two sets, from the third week to the end The course is carried out in three sets with a intensity of 75% one maximum repetition.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fibroblast growth factor 21. Timepoint: Blood samples were taken at once in the first stage(pre-test) and secondly(post-test) after 8 weeks of exercise. Method of measurement: Fibroblast growth factor factor 21 kit.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Blood samples were taken once in the first stage(pre-test) and the second time(post-test) after 8 weeks of training. Method of measurement: Formula for evaluation of insulin resistance homeostasis model(HOMA-IR).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glucose. Timepoint: Blood samples were taken once in the first stage (pre-test) and the second time (post-test) after 8 weeks of training. Method of measurement: Glucose Kit and Colorimetric Enzymatic Method.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Blood samples were taken once in the first stage (pre-test) and the second time (post-test) after 8 weeks of training. Method of measurement: Insulin kit and Elisa method.</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>Shahrood University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-02</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, Seventh Tir Square, Shahrood University of Medical Sciences Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
