<?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>IRCT20171018036870N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-26</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance  in adipose tissue of diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance (IRS-1/PI3K/Akt/mTOR/GLUT4)  in adipose tissue of diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Type 2 Diabetes Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: We have two intervention groups:                            Group 1: This group only receive metformin for 3 months.                                                                                                                                                                                                     Metformin:  Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner. Intervention 2: Intervention group:                                                                                     Group 2: This group receive metformin and sitaglyptin simultaneously for 3 months.Metformin:  Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner.                                                                   Sitaglyptin: Branded Januvia, 50mg manufactured by England, licensed to Merck, twice a day, in the morning after breakfast and at night after dinner. Intervention 3: Control group: 5 non-immune non-insulin-dependent non-insulin-dependent individuals. These people do not use any drugs.</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:
If individual data is available to participants without a first and last name, access to them is possible

When:
forever

To whom:
All medical field researchers

Conditions:
Only for observation is allowed.

Where to obtain:
Visit Iranian Randomized Clinical Trial

How to obtain:
Users should certainly mention the name of the Iranian Randomized Clinical Trials as a source.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Didehdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd-Boulevard, PrMolecular Biology and Biochemistry Dpt.- Medical Faculty- Medical Sciences Pardis- Anonymous Martyrs Bivd- Professor Hassabi-Blvd- Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173143</zip>
        <telephone>+98 35 3820 3417</telephone>
        <email>didehdar@zbmu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Didehdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Biochemistry and Molecular Biology Dept.- Faculty of Medicine- Campus of Meical Sciences University- Anonymous Martyrs Blvd- Professor Hassabi Blvd- Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173143</zip>
        <telephone>+98 35 3820 3410</telephone>
        <email>didehdar@zbmu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 2 diabetes who have not yet taken medication and are recently diagnosed with a blood glucose test, the so-called New Case.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetics who are taking medications, taking pills or taking insulin, have been eliminated.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>diabetes (mellitus)(nonobese)(obese):          adult-onset         maturity-onset         nonketotic         stable         type II      non-insulin-dependent diabetes of the young</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: We have two intervention groups:                            Group 1: This group only receive metformin for 3 months.                                                                                                                                                                                                     Metformin:  Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner.</i_keyword>
      <i_keyword>Intervention group:                                                                                     Group 2: This group receive metformin and sitaglyptin simultaneously for 3 months.Metformin:  Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner.                                                                   Sitaglyptin: Branded Januvia, 50mg manufactured by England, licensed to Merck, twice a day, in the morning after breakfast and at night after dinner.</i_keyword>
      <i_keyword>Control group: 5 non-immune non-insulin-dependent non-insulin-dependent individuals. These people do not use any drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance IRS-1/PI3K/Akt/mTOR/GLUT4. Timepoint: Measuring the proteins involved in insulin resistance at the beginning of the study (before metformin and citagliptin therapy) and in 90 days (3 months) of drug use (after treatment with metformin and sitagliptin). Method of measurement: How to measure these proteins using SDS-PAGE and Western blotting.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-18</approval_date>
        <contact_name>Ethics committee of of Shahid Sadoughi Yazd University of Medical Sciences</contact_name>
        <contact_address>Molecular Biology Dept. - Medical Faculty- Campus of Shahid Sadoughi University of Medical Sciences - Anonymous Martyrs Blvd- Professor Hesabi Blvd- Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
