<?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>IRCT20221120056548N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-09</date_registration>
      <primary_sponsor>Vice President of Research at Danesh Alborz University</primary_sponsor>
      <public_title>Effect of exercise and consumption of garlic extract on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of resistance training and consumption of garlic Extract on some biomarkers of oxidative stress, malondialdehyde (MDA) and reduced glutathione (GSH) in women with hyperlipidemia and type 2 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this randomization, the method of equal blocks (15 blocks of 4) has been used, in which a number of intervention people and a number of comparison people are included in each block, and we have allocated them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Sports intervention includes 8 weeks of combined exercises (selected aerobic and resistance exercises). According to the instructions of the American College of Sports Medicine (ACSM), the participants start training three times a week for fifty minutes, and the intensity and duration of the training is increased during 8 weeks. All exercises are performed under the supervision of a sports physiology specialist and in the health sports clinic. During eight weeks of resistance training, in each training session, the subjects performed three lower body movements (leg press, front thigh press, and back thigh press) and six upper body movements (chest press, cable underarm, lateral push, cable back arm, front arm, and crunch). base) will be performed by starting the lower body movements and then the upper body with an intensity of 80% of a maximum repetition. These exercises will include three sets of 10 repetitions for both upper and lower body parts with 1 minute rest between sets and movements. The supplement group will be given a daily garlic capsule - each containing 500 mg of garlic extract supplement (produced by Goldaro, Iran) - for 8 weeks, and the third group will exercise and take the supplement at the same time. Intervention 2: Control group: This group is not subjected to any exercise intervention and supplement consumption.</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 data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions.

Conditions:
If the intellectual rights are preserved, the data can be sent to the researchers.

Where to obtain:
Email address: saeidshamlou9092@gmail.com

How to obtain:
Submission of a written request (one week)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Shamlou Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Shamlou Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diabetes
high blood fat
being menopausal</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cardiovascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Sports intervention includes 8 weeks of combined exercises (selected aerobic and resistance exercises). According to the instructions of the American College of Sports Medicine (ACSM), the participants start training three times a week for fifty minutes, and the intensity and duration of the training is increased during 8 weeks. All exercises are performed under the supervision of a sports physiology specialist and in the health sports clinic. During eight weeks of resistance training, in each training session, the subjects performed three lower body movements (leg press, front thigh press, and back thigh press) and six upper body movements (chest press, cable underarm, lateral push, cable back arm, front arm, and crunch). base) will be performed by starting the lower body movements and then the upper body with an intensity of 80% of a maximum repetition. These exercises will include three sets of 10 repetitions for both upper and lower body parts with 1 minute rest between sets and movements. The supplement group will be given a daily garlic capsule - each containing 500 mg of garlic extract supplement (produced by Goldaro, Iran) - for 8 weeks, and the third group will exercise and take the supplement at the same time.</i_keyword>
      <i_keyword>Control group: This group is not subjected to any exercise intervention and supplement consumption.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people whose blood sugar levels have decreased. Timepoint: Blood sugar measurement before and after the intervention. Method of measurement: By measuring blood sugar in the laboratory.</prim_outcome>
      <prim_outcome>The percentage of people whose blood fat level has decreased. Timepoint: Measurement of blood lipids before and after the intervention. Method of measurement: By measuring blood lipids in the laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The percentage of people in whom the level of antioxidant glutathione increased and malondialdehyde decreased. Timepoint: Before and after interventions. Method of measurement: Using ELISA method and Zelbio kit made in Germany.</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>Vice President of Research at Danesh Alborz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-21</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>Fifth Alley, Mir Emad Ave., Ostad Motahari Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
