<?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>IRCT20181219042056N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-13</date_registration>
      <primary_sponsor>Vice president of of Research of Tehran University</primary_sponsor>
      <public_title>Comparison of Continuous Moderate-Intensity Training and High-Intensity Interval Training on Vasodilators And Cardiac Function in Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Continuous Moderate-Intensity Training and High-Intensity Interval Training on Vasodilators And Cardiac Function in Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>47</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized to Intervention And Control Groups. 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 15 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 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Doing 12 weeks continuous moderate-intensity training (70 % Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal. Intervention 2: Intervention group 2: Doing 12 weeks High-Intensity Interval Training (85-90% Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal. 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of data

When:
1 year after publish

To whom:
All of people

Conditions:
For scientific study

Where to obtain:
Salehi.1371@ut.ac.ir

How to obtain:
In First Time After observetion in Email Adress

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ramin Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14398-13117</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>salehi.1371@ut.ac.ir</email>
        <affiliation>Vice president of of Research of Tehran University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14398-13117</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>salehi.1371@ut.ac.ir</email>
        <affiliation>Vice president of of Research of Tehran University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 45 to 60 years.
According to Defined by American Diabetes Association 2015, fasting blood sugar (FBS) more than 7 mmol/L.
Glycosylated Haemoglobin (HbA1c) above 6%.
Type 2 Diabetes.
Pre- or stage I hypertension, or treated hypertension (systolic blood pressure 120–159 mmHg, diastolic blood pressure 80–99 mmHg).
Patients with history of Type 2 Diabetes for at least 2 years.
No exercise training in the previous 6 months.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with FBS more than 22 mmol/L.
HbA1c above 10%.
Myocardial infarction, coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmia, functional limitations (such as osteoarthritis), liver or kidney disease, and smoking.
Hypertension, or treated hypertension (systolic blood pressure 170 mmHg, diastolic blood pressure 100 mmHg).</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 group 1: Doing 12 weeks continuous moderate-intensity training (70 % Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal</i_keyword>
      <i_keyword>Intervention group 2: Doing 12 weeks High-Intensity Interval Training (85-90% Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal</i_keyword>
      <i_keyword>Control group: normal condition without any exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adropin Factor. Timepoint: Before and After from 12 week exercise. Method of measurement: Using the Laboratory Elisa Kit.</prim_outcome>
      <prim_outcome>Nitrite/Nitrate plasma. Timepoint: Before and After from 12 week exercise. Method of measurement: Using the Laboratory Elisa Kit.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Before and After from 12 week exercise. Method of measurement: HOMA-IR.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Before and After from 12 week exercise. Method of measurement: Enzymatic.</prim_outcome>
      <prim_outcome>Peak consumption oxygen. Timepoint: Before and After from 12 week exercise. Method of measurement: Gas analyser system.</prim_outcome>
      <prim_outcome>Diastolic and systolic blood pressure. Timepoint: Before and After from 12 week exercise. Method of measurement: oscillometric device.</prim_outcome>
      <prim_outcome>Heart rate rest. Timepoint: Before and After from 12 week exercise. Method of measurement: Cornometer/ numbere.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and After from 12 week exercise. 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>2018-04-21</approval_date>
        <contact_name>Ethics Committee of Faculty of Physical Education and Sport Sciences - University of Tehran</contact_name>
        <contact_address>Tehran Province, Tehran, North Kargar Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
