<?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>IRCT20220510054809N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-27</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>Effect of Aerobic Training with Vitamin D Supplementation on Gene Expression of Visceral Adipose Tissue of Obese Rats with Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Eight Weeks Aerobic Training with Vitamin D Supplementation on AMPK, PGC-1a, PTP1B, and UCP-1 Gene Expression in The Visceral Adipose Tissue of Obese Rats with Type 2 Diabetes</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/63633</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, 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: At first, any qualified rat got a specific code. then, the codes was written on a similar piece of paper and placed in the first vase. Also, the name of groups was written on a similar piece of paper and placed in the second vase. In the following, after blending the papers in any vase, a code were drawn from first vase and assigned to the group that its name were drawn from the second vase, respectively. In case of completing the desired members of any group before ending the lottery, the name of that group was excluded from its vase.</study_design>
      <phase>N/A</phase>
      <hc_freetext>type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1; Aerobic training (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks. Intervention 2: Intervention group 2; Aerobic training + Vitamin D supplementation (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU. Intervention 3: Intervention group 3; Vitamin D supplementation (type 2 diabetes): 5000 IU vitamin D supplementation per week for 8 weeks. Intervention 4: Intervention group 4; Aerobic training (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks. Intervention 5: Intervention group 5; Aerobic training + Vitamin D supplementation (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU. Intervention 6: Intervention group 6; Vitamin D supplementation (obese without diabetes): 5000 IU vitamin D supplementation per week for 8 weeks. Intervention 7: Control group 1; Control (type 2 diabetes): 8 weeks of receiving placebo, without aerobic exercise. Intervention 8: Control group 2; Control (obese without diabetes): 8 weeks of receiving placebo, without aerobic exercise. Intervention 9: Sham group: Being on treadmill without doing 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:
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:
All the data are usable with consideration of the authors rights.

Where to obtain:
1- Dr. Rastegar Hosseini (rastegar.hoseini@gmail.com).
2- kimya khaledi (kimyakhaledi19@gmail.com).

How to obtain:
For this purpose one can send their request via e-mail to the aforementioned persons; after reviewing the request, in case of discretion, the related data will be presented to them. This process can take long between 3 to 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rastegar Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 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>6714967346</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>R.hoseini@razi.ac.ir</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rastegar Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 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>6714967346</zip>
        <telephone>0098 34279265</telephone>
        <email>R.hoseini@razi.ac.ir</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between8 to 9 months old
Male sex
To have type 2 diabetes in diabetic groups
To have a minimum of 300 gram of weight
No to have type 2 diabetes in non-diabetic obese groups</inclusion_criteria>
      <agemin>8 months</agemin>
      <agemax>9 months</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Movement disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes</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 1; Aerobic training (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks</i_keyword>
      <i_keyword>Intervention group 2; Aerobic training + Vitamin D supplementation (type 2 diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU</i_keyword>
      <i_keyword>Intervention group 3; Vitamin D supplementation (type 2 diabetes): 5000 IU vitamin D supplementation per week for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 4; Aerobic training (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 5; Aerobic training + Vitamin D supplementation (obese without diabetes): Aerobic exercise between 25-60 minute with 50-60% of maximum oxygen consumption, 5 times per week for 8 weeks; 5000 IU</i_keyword>
      <i_keyword>Intervention group 6; Vitamin D supplementation (obese without diabetes): 5000 IU vitamin D supplementation per week for 8 weeks</i_keyword>
      <i_keyword>Control group 1; Control (type 2 diabetes): 8 weeks of receiving placebo, without aerobic exercise</i_keyword>
      <i_keyword>Control group 2; Control (obese without diabetes): 8 weeks of receiving placebo, without aerobic exercise</i_keyword>
      <i_keyword>Sham group: Being on treadmill without doing exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AMPK Gene Expression. Timepoint: Before intervention; after intervention. Method of measurement: Western-Blot method using Kiagen Kit With 0/021 Pg/mL sensitivity.</prim_outcome>
      <prim_outcome>Expression Of PGC-1a Gene. Timepoint: Before intervention; after intervention. Method of measurement: Real time-PCR Method using Mirnasy mini kit50 Kit With 0/06 ng/mL sensitivity.</prim_outcome>
      <prim_outcome>Expression Of PTP1B Gene. Timepoint: Before intervention; after intervention. Method of measurement: Real time-PCR Method using RNeasy Commercial Kit With 0/06 ng/mL sensitivity.</prim_outcome>
      <prim_outcome>Expression Of UCP-1 Gene. Timepoint: Before intervention; after intervention. Method of measurement: Eliza Double Sandwich Method using Cat no: ZB-11252-R9648 Kit With 0/06 ng/mL sensitivity.</prim_outcome>
      <prim_outcome>Insulin Resistance Index. Timepoint: Before intervention; after intervention. Method of measurement: Serum Insulin by Elisa Method using Micro-calorie Metric Kit With 5/5 mg/dl Sensitivity. Insulin Resistance Index will be Determined Using Glucose And Insulin Concentrations And HOMA-IR formula.HOMA-IR= (Glucose Concentration × Insulin Concentration)÷22/5.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Irisin Expression Gene. Timepoint: Before intervention; after intervention. Method of measurement: Eliza Method using EASTBIOPHARM Kit With 0/023 mg/mL sensitivity.</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>2022-04-19</approval_date>
        <contact_name>Ethics committee in research of Razi University of Kermanshah</contact_name>
        <contact_address>No. 9, 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>
