<?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>IRCT20220512054832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-09</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>The Effect of Aerobic Training with Vitamin D Supplementation on Cardiomyocytes Gene Expression of Type 2 Diabetic Rats.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on Cardiac Biomarkers, VEGF-B Protein Levels, IGF-1 and Mir-1 Gene Expression in Cardiomyocytes of Type 2 Diabetic Rats.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63522</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Basic scienece, Other design features: In this study, there are three training, supplementation, and training with supplementation groups in diabetic models; three training, supplementation, and training with supplementation groups in non-diabetic obese models; a diabetic group that receives a placebo; a non-diabetic obese group that receives a placebo; and a sham group, Randomization description: Random number tables were used for randomization. For this purpose, every 90 rats got a specific number from 1 to 90. Then, using the RAND function of Excel software (Microsoft Corporation, 2019 version), the random number table was produced. Randomly, with closed eyes, one of the excel worksheet cells was clicked on; that number was considered the origin. Because 90 (subjects quantity) is a two-digit number, the first two digits of the numbers listed on the table were read. In case of being in the range of 1 to 90, that number was allocated to the related group. About the group order that is presented in the intervention groups part, the first 10 numbers were allocated to the first group (Aerobic training, type 2 diabetic models). The members of other groups were chosen in this way, too; that is, the second 10 numbers were allocated to the second group, the third 10 numbers to the third group, and so on.</study_design>
      <phase>N/A</phase>
      <hc_freetext>type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one (Aerobic training, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week). Intervention 2: Intervention group two (Aerobic training with vitamin D supplementation, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week). Intervention 3: Intervention group three (Vitamin D supplementation, type 2 diabetic models): Receiving vitamin D for eight weeks (5000 IU per week). Intervention 4: Intervention group four (Aerobic training, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week). Intervention 5: Intervention group five (Aerobic training with vitamin D supplementation, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week). Intervention 6: Intervention group six (Vitamin D supplementation, non-diabetic obese models): Receiving vitamin D for eight weeks (5000 IU per week). Intervention 7: Control group one (type 2 diabetic models): Receiving placebo without aerobic training for eight weeks. Intervention 8: Control group two (non-diabetic obese models): Receiving placebo without aerobic training for eight weeks. Intervention 9: Sham group: The subjects of this group are just placed on the treadmill and do not do aerobic 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:
All the data are presentable.

When:
The data can be accessed 9 months after their publication.

To whom:
Only researchers of academic and scientific institutes can access the data.

Conditions:
Considering the author's rights, all the data can be utilized.

Where to obtain:
1- Dr. Rastegar Hosseini (rastegar.hoseini@gmail.com).
2- Fatemeh Mazaheri (fatemehmazaheri377@gmail.com).

How to obtain:
At first, one will send their request via email. After revision and in case of expediency, in 3-10 working days, the related information will be presented to them.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rastegar Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>rastegar.hoseini@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rastegar Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Education and Sports Science College, Razi University, Razi Blvd, Taq-e Bostan Ave</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>rastegar.hoseini@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 2 to 3 months old
To have a minimum of 300 gram of weight
To have type 2 diabetes in diabetic groups
No to have type 2 diabetes in non-diabetic obese groups
Male sex</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>3 months</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Movement disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group one (Aerobic training, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week).</i_keyword>
      <i_keyword>Intervention group two (Aerobic training with vitamin D supplementation, type 2 diabetic models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week).</i_keyword>
      <i_keyword>Intervention group three (Vitamin D supplementation, type 2 diabetic models): Receiving vitamin D for eight weeks (5000 IU per week).</i_keyword>
      <i_keyword>Intervention group four (Aerobic training, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week).</i_keyword>
      <i_keyword>Intervention group five (Aerobic training with vitamin D supplementation, non-diabetic obese models): Aerobic training for eight weeks (50-60% of maximum oxygen consumption for 25-60 minutes, five times per week); Receiving vitamin D for eight weeks (5000 IU per week).</i_keyword>
      <i_keyword>Intervention group six (Vitamin D supplementation, non-diabetic obese models): Receiving vitamin D for eight weeks (5000 IU per week).</i_keyword>
      <i_keyword>Control group one (type 2 diabetic models): Receiving placebo without aerobic training for eight weeks.</i_keyword>
      <i_keyword>Control group two (non-diabetic obese models): Receiving placebo without aerobic training for eight weeks.</i_keyword>
      <i_keyword>Sham group: The subjects of this group are just placed on the treadmill and do not do aerobic training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac biomarkers. Timepoint: Before &amp; after the intervention. Method of measurement: Elisa kit (Elabscience Company) with a sensitivity of 18,75 Pg/mL.</prim_outcome>
      <prim_outcome>Vascular Endothelial Growth Factor B. Timepoint: Before &amp; after the intervention. Method of measurement: Elisa kit (BT-LAB Company) with a sensitivity of 5.01 ng/L.</prim_outcome>
      <prim_outcome>MicroRNA 1. Timepoint: Before &amp; after intervention. Method of measurement: Polymerase chain reaction (PCR) method using The Corbett Research Rotor-Gene 6000 (QIAGEN company) and The miScript SYBR Green PCR Kit (QIAGEN company) with a sensitivity of 1.55 ng/ml.</prim_outcome>
      <prim_outcome>Insulin-like growth factor 1. Timepoint: Before &amp; after the intervention. Method of measurement: Polymerase chain reaction (PCR) method using The Corbett Research Rotor-Gene 6000 (QIAGEN company) and The Transcriptor First Strand cDNA Synthesis Kit (Roche company) with a sensitivity of 1.55 ng/ml.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before &amp; after the intervention. Method of measurement: Photometry method using Pars Azmoun company kits. The sensitivity of serum level assay kit for LDL Cholesterol, HDL Cholesterol, Triglyceride, and Glucose equals 12.098 mg/dL, 22.714 mg/dL, 35.087 mg/dL, and 25.497 mg/dL, respectively.</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>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-20</approval_date>
        <contact_name>Research ethics committee of Razi University of Kermanshah</contact_name>
        <contact_address>Razi University, Daneshgah Blvd, Taq-e Bostan Ave Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
