<?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>IRCT20211229053561N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Islamic Azad University of Khorasgan Branch</primary_sponsor>
      <public_title>The effect of exercise and bee propolis supplement on type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of combined training (resistance-aerobic) and propolis supplementation on serum levels of adipolin (CTRP12) and secretory protein associated with secretory curvature (SFRP5) and Interleukin 6 (IL6) and glycemic indexes in women with type 2 diabetes with dyslipidemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, subjects are randomly selected according to the law of random allocation. In this way, after determining the sample size, people will be equally divided into four groups (combined exercise + supplement, combined exercise + placebo, placebo, supplement), Blinding description: Patients in the supplement and exercise + supplement group take 3 tablets with a dose of 300 mg of propolis for eight weeks three times a day one hour after each meal. The placebo and placebo + exercise groups receive the same amount of placebo. Since the placebo and propolis supplement are placed inside the capsule in exactly the same way, participants and researchers are not aware of the type of supplement they receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group, combined training + placebo (simultaneous intervention of combined training, which includes 20 minutes of aerobic training and 45 minutes of resistance training, 3-4 sessions per week, and training for 8 weeks from low to high intensity and following the principle of extra Once done, we will take placebo pills). Intervention 2: Intervention group 2: Supplement group (3 tablets of 300 mg of bee propolis daily one hour after each meal with a glass of water and no exercise is done during the intervention period). Intervention 3: Intervention group: Combined exercise + supplement group (in this group, we will have simultaneous intervention exercise + propolis supplement, similar to the same protocol described in the previous section. Intervention 4: Control group: placebo group (this group of patients receive 3 tablets of the same shape, color and size of placebo daily and with the same protocol of the intervention group).</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh moayedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 88, 25 meters from Shahid Sheikhi, South Hemmat, Moallem Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۸۵۹۹۹۱۱۵</zip>
        <telephone>+98 71 3632 2954</telephone>
        <email>Fatemeh_m8040@yahoo.com</email>
        <affiliation>Islamic Azad University of Khorasgan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh moayedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 88, 25 meters from Shahid Sheikhi, South Hemmat, Moallem Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۸۵۹۹۹۱۱۵</zip>
        <telephone>+98 71 3632 2954</telephone>
        <email>Fatemeh_m8040@yahoo.com</email>
        <affiliation>Islamic Azad University of Khorasgan Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of type 2 diabetes (fasting blood sugar greater than 126 mg / dL, oral glucose tolerance test equal to or greater than 200 mg / dL, glycosylated hemoglobin 5.6% or higher) Body mass index between 27 Up to 35, age 40 to 60 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Insulin use, having cardiovascular disease, musculoskeletal disease, liver disease, kidney disease, thyroid disorder, having a history of regular physical activity for at least the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent 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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group, combined training + placebo (simultaneous intervention of combined training, which includes 20 minutes of aerobic training and 45 minutes of resistance training, 3-4 sessions per week, and training for 8 weeks from low to high intensity and following the principle of extra Once done, we will take placebo pills).</i_keyword>
      <i_keyword>Intervention group 2: Supplement group (3 tablets of 300 mg of bee propolis daily one hour after each meal with a glass of water and no exercise is done during the intervention period).</i_keyword>
      <i_keyword>Intervention group: Combined exercise + supplement group (in this group, we will have simultaneous intervention exercise + propolis supplement, similar to the same protocol described in the previous section.</i_keyword>
      <i_keyword>Control group: placebo group (this group of patients receive 3 tablets of the same shape, color and size of placebo daily and with the same protocol of the intervention group).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interleukin 6. Timepoint: Before the intervention and 48 hours after the intervention. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Adipolin. Timepoint: Before the intervention and 48 hours after the intervention. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Secreted frizzled-related protein 5. Timepoint: Before the intervention and 48 hours after the intervention. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Before and after the protocol. Method of measurement: Mg /dL by blood test.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before and after the protocol. Method of measurement: Laboratory and biochemical methods.</sec_outcome>
      <sec_outcome>Low density lipoprotein cholesterol. Timepoint: Before and after the protocol. Method of measurement: Laboratory and biochemical methods.</sec_outcome>
      <sec_outcome>High-density lipoprotein cholesterol. Timepoint: Before and after the protocol. Method of measurement: Laboratory and biochemical methods.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Before and after the protocol. Method of measurement: Laboratory and biochemical methods.</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>Islamic Azad University of Khorasgan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-22</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Khorasgan Branch</contact_name>
        <contact_address>University Boulevard, Arghavanieh, East J. Street Khorasgan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
