<?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>IRCT20230419057962N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-23</date_registration>
      <primary_sponsor>Razi university of Kermanshah</primary_sponsor>
      <public_title>Investigating the effects of performing resistance training and consuming cucumber juice in women with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the separate and combined effects of resistance training and cucumber (cucumis sativus) juice consumption on diabetic, lipid, oxidative and hepatic indices status of women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69693</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Other, Randomization description: The current research is an experimental type with a pretest-posttest design and random assignment of research groups (three experimental groups and one control group). For this purpose, 40 women (35 to 70) years old with type 2 diabetes who had visited the Kermanshah Diabetes Treatment Research Center were selected and randomly divided into four groups of 10 including  Training and Placebo group, Training and Supplement group, Supplement group and Control group were included.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention groups: first group: (training and placebo group) , second group: (training and supplement group ), third group: supplement group, fourth group: control group. The first group: received eight weeks of resistance training along with 240 ml of placebo. The second group: eight weeks of resistance training and received 240 ml of cucumber juice. The third group received 240 ml of cucumber juice for eight weeks. The control group received 240 ml of placebo for eight weeks. The research protocol lasted eight weeks (24 sessions). For the preparation of the placebo, edible green dye (retg, an authorized synthetic liquid edible dye, manufactured by the Yellow Line factory, under the standard of the Food and Drug Organization (I.R.I. FDO)) was used..</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:
After collecting the data by the researcher, it is the responsibility of the researcher to analyze the data. The data of the participants will be analyzed without mentioning their names, and after the data analysis, an article about the research data will be printed. The data file of the participants will be kept by the researcher and the results of the data analysis will be The article format will be printed. The informed consent form of the participants will be placed with the researcher and if needed, the journal or relevant authorities will be informed. The study protocol and clinical study report will be published in the form of an article. The codes used in the analysis (code of ethics) will be written in the article.

When:
After publishing the article

To whom:
The referees of the journal in which the article is to be published

Conditions:
For further review and close monitoring of published data

Where to obtain:
Applicants (reviewers of the journal) can contact the main researcher of the research through the postal address: Kermanshah., Taqbestan., University Ave., Razi University., Kermanshah, or send an email to the email address m.lotfi7344@gmail.com, or contact the main researcher of the research (Maryam Lotfi) through correspondence with the number 00989032215055 to receive the desired documents or data.

How to obtain:
The referees of the desired journal can send an email to the main researcher and request that the data of the protocol be served to them(in order to publish an article in the desired magazine).

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Lotfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Ave., Taq Bostan., Razi University</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۷۱۴۴۱۴۹۷۱</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>m.lotfi7344@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Lotfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Ave., Taq Bostan., Razi University</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۷۱۴۴۱۴۹۷۱</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>m.lotfi7344@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with type 2 diabetes
Not using Insulin and not having diabetes complications, including diabetic foot ulcers
No history of any Cardiovascular, Kidney or Cancer disease in the last 5 years
Lack of regular sports activity during the last six months
Having a Health Certificate from a doctor to do sports activities</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Inability to do resistance training
Pregnancy or Breastfeeding
Use of Drugs or Supplements (such as Corticosteroids and Anabolic hormones)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groups: first group: (training and placebo group) , second group: (training and supplement group ), third group: supplement group, fourth group: control group. The first group: received eight weeks of resistance training along with 240 ml of placebo. The second group: eight weeks of resistance training and received 240 ml of cucumber juice. The third group received 240 ml of cucumber juice for eight weeks. The control group received 240 ml of placebo for eight weeks. The research protocol lasted eight weeks (24 sessions). For the preparation of the placebo, edible green dye (retg, an authorized synthetic liquid edible dye, manufactured by the Yellow Line factory, under the standard of the Food and Drug Organization (I.R.I. FDO)) was used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Biochemical markers of diabetic indicators. Timepoint: 48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test). Method of measurement: Blood sampling and evaluation of samples by laboratory kits.</prim_outcome>
      <prim_outcome>Biochemical markers of lipid profile. Timepoint: 48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test). Method of measurement: Blood sampling and evaluation of samples by laboratory kits.</prim_outcome>
      <prim_outcome>Biochemical markers of oxidative indices. Timepoint: 48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test). Method of measurement: Blood sampling and evaluation of samples by laboratory kits.</prim_outcome>
      <prim_outcome>Biochemical markers of liver indices. Timepoint: 48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test). Method of measurement: Blood sampling and evaluation of samples by laboratory kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Height measurement. Timepoint: 48 hours before the start of the protocol. Method of measurement: Yagami model gauge made in Japan.</sec_outcome>
      <sec_outcome>Weight measurement. Timepoint: 48 hours before the start of the protocol. Method of measurement: 1. Beurer digital scale, model PS07, made in Germany, with an accuracy of 0.1 kg.</sec_outcome>
      <sec_outcome>Body composition measurement. Timepoint: 48 hours before the start of the protocol. Method of measurement: Zeus 9.9 plus body composition analyzer made in South Korea.</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>2021-12-29</approval_date>
        <contact_name>The ethics committee in biomedical research of Razi university</contact_name>
        <contact_address>University Ave., Taqbostan Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
