<?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>IRCT20200201046326N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-03</date_registration>
      <primary_sponsor>The University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>The effect of different genotypes of adiponectin gene on diabetes response to exercise</public_title>
      <acronym></acronym>
      <scientific_title>Survey on  the synergistic effect of some adiponectin gene polymorphisms in response to aerobic training with two different intensities in middle-aged men with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45713</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, the total sample size of 150 people after screening was determined as the research sample, then using random allocation method, 50 balls were considered for the first intervention group, 50 balls for the second intervention group and another 50 balls for the control group. These balls were placed in a lottery container, then balls were randomly removed from the container without replacement and the sequence created was recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In this group, 50 diabetic patients perform low intensity aerobic exercise (65% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute).The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine. Intervention 2: Intervention group 2: In this group, 50 diabetic patients perform high intensity aerobic exercise (80% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute). The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine. Intervention 3: Control group: 50 diabetic patients who will not have regular exercise for 12 weeks.</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:
Part of the data related to the distribution of the 5 polymorphisms studied will be shared.

When:
Start of access period 6 months after  publication of Results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers in this field who have a larger statistical sample than our research

Where to obtain:
Elaheh Mamashli, PhD student of Mohaghegh Ardabili University,
Mamashli.elahe@gmail.com
09115327323

How to obtain:
After receiving the request, the data will be sent after informing the other participants in this research

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Mamashli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Mohaghgegh Ardabili, University Street</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 17 3522 9933</telephone>
        <email>mamashli.elahe@gmail.com</email>
        <affiliation>The University of Mohaghgegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Mamashli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, University Street, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 17 3522 9933</telephone>
        <email>Mamashli.elahe@gmail.com</email>
        <affiliation>The University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All diabetic patients who have more than 12 years history of diabetes
Hemoglobin A1c above 7
Age under 65 years old</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>People with a history of cardiovascular disease and cancer
Diabetic foot ulcer
Having an amputation
Severe retinopathy
Having neurological and orthopedic disorders
Having regular physical activity for the past 6 months</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In this group, 50 diabetic patients perform low intensity aerobic exercise (65% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute).The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine.</i_keyword>
      <i_keyword>Intervention group 2: In this group, 50 diabetic patients perform high intensity aerobic exercise (80% of maximal oxygen consumption) for 12 weeks, 3 sessions per week. The content of a training session will include dynamic stretching movements in the warm-up (10 minute) and cool-down (7 minute) sections and Jogging for the main section (10 minute). The intensity and type of exercises are designed according to the standards and recommendations of the American College of Sports Medicine.</i_keyword>
      <i_keyword>Control group: 50 diabetic patients who will not have regular exercise for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adiponectin. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Adiponectin ELISA kit.</prim_outcome>
      <prim_outcome>Five polymorphisms of the adiponectin gene. Timepoint: Before 12 weeks of aerobic exercise. Method of measurement: DNA extraction and pcr method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemoglobin A1c. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Using the HbA1c kit and the enzyme method (Diazyme).</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Quantitative diagnostic kit (glucose oxidase), by enzymatic photometric method.</sec_outcome>
      <sec_outcome>Low-density lipoprotein(LDL). Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Relevant diagnostic kit, Enzymatic method.</sec_outcome>
      <sec_outcome>High-density lipoprotein (HDL). Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Relevant diagnostic kit, Enzymatic method.</sec_outcome>
      <sec_outcome>Total Cholesterol. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Relevant diagnostic kit, Enzymatic method.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Relevant diagnostic kit, Enzymatic method.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after 12 weeks of aerobic exercise. Method of measurement: Using a mercury sphygmomanometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Ardabil University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Mohaghegh Ardabili</source_name>
      <source_name>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-02</approval_date>
        <contact_name>Ethics Committee in Biomedical Research of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Research Ethics Committee, North side of Ardebil University of Medical Sciences, University Square, University Street Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
