<?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>IRCT20230628058611N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Pilates training on type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Pilates training on serum levels of Irisin, Ghrelin, lipid profile and appetite in women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: How to randomize: The online random number generation site at the address kitset.ir/numbers/random was used and the no duplicate numbers were ticked and 15 numbers were selected among 30 subjects and numbers of 15,9,28,8,16,13,12,30,11,3,21,29,26,5,1 were placed in the test group and numbers of 14,6,18,7,4,27,20,10,2,23,17,19,25,24,22 were placed in the control group, Blinding description: Participant: People in the control group do not know about the exercises of the training group, and the training group does not know about the control group.
The subjects are blind in both groups.
Coach: He doesn't know about the training group.
The outcome evaluator: He doesn't know about being two groups and the protocol of exercise.
Data analyzer: It has no relationship with subjects, coach, and training protocol.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and undergo 12-weeks Pilates training, 3 sessions per week, 50 minutes per each session, with an intensity of 70 to 80% of the maximum heart rate. Intervention 2: Control group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and this group continues their daily life and does not have any special plan.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Talebi Najafabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 35, Abdulahi Deadend, Riyazi St., Shariati St.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8513677891</zip>
        <telephone>+98 31 4262 9350</telephone>
        <email>talebiazam26@gmail.com</email>
        <affiliation>Islamic Azad University of Najafabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Talebi Najafabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 35,Abdulahi Deadend, Riyazi St., Shariati St.</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8513677891</zip>
        <telephone>+98 31 4262 9350</telephone>
        <email>talebiazam26@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: Between 35 to 55 years old
Fasting Blood Sugar: Equal to or more than 126 to 250
History: At least one year history of Diabetes
Ability to do exercise
Use of oral medication</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Doing exercise regularly
Having back pain and neck pain
Use of injectable insulin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus type 2</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and undergo 12-weeks Pilates training, 3 sessions per week, 50 minutes per each session, with an intensity of 70 to 80% of the maximum heart rate.</i_keyword>
      <i_keyword>Control group: It includes 15 women with type 2 diabetes (members of Jenan Diabetes Association) who meet the inclusion criteria of the study and this group continues their daily life and does not have any special plan.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Irisin. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Ghrelin. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and 48 hours after the study. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Amount of appetite. Timepoint: Before and 48 hours after the study. Method of measurement: (Questionnaire) Visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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>Najafabad Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-30</approval_date>
        <contact_name>Ethics Committee of Najafabad Azad University</contact_name>
        <contact_address>Najafabad Azad University, University Boulevard, Najafabad Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
