<?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>IRCT20180711040425N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-10</date_registration>
      <primary_sponsor>Shahroud University of Technology</primary_sponsor>
      <public_title>The effect of exercise intensity and supplementation on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 4 weeks high-intensity interval training (HIIT) with Spirulina supplementation on serum total antioxidant capacity (TAC) and Malondialdehyde  (MDA) in women with type 2 diabetes (T2D)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32893</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Basic scienece, Randomization description: To allocate participants to research groups, a computer inventory of random numbers using a computer software (Random Allocation Software 2.0) will first be created by one of the research colleagues.Allocate participants by one of the research team members that is not related to the participants is done by block randomization with 4 blocks within the experimental (training) and control groups. Participants will be classified into 4 groups using randomized block method, depending on their blood glucose variables. The limitation of this method is the prediction of final allocation, which is the solution of random use of blocks of different sizes.
Assignment sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: The training group consisted of three sessions per week of high intensity interval training for 4 weeks. Training sessions consisted of 45 minutes walk or running on a treadmill. Each session is divided into 10 minutes of warming up with an intensity 50-70% HRR, 10 minutes of cooling down with an intensity 50-70% HRR  and 25 minutes of high intensity interval training ( HIIT The training section consists of 4 4-minute sections, with an intensity of 85 to 95% HRR and 3-minute rest periods, with an intensity of 50-70% HRR). Intervention 2: Spirulina 2 grams daily, including 4 pills 500 mg before meals, for 4 weeks. This supplement is made by Qeshm algae and contains spirulina pure green algae. spirulina is a blue-green wonder aglae. It is the most powerful food existing in nature with 60% protein content and 18 amino acids. Intervention 3: Third intervention group: Exercise + supplement group consisting of three sessions per week of high intensity interval training for 4 weeks and 2 grams of supplementation of spirulina per day for 4 weeks. Intervention 4: fourth intervention group:  control group, No Spirulina supplement and no exercise.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>saeedeh khodadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud Industrial University, Haft-e Tir Square</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ss.kk1159@yahoo.com</email>
        <affiliation>Shahroud University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeedeh Khodadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ss.kk1159@yahoo.com</email>
        <affiliation>Shahrood university of technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>T2D detection &lt; 10 years ago
Ages 40 to 65 years old
No dependency to insulin
The use of commonly used diabetes medications, such as metformin and glenalbelamine</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular disease
Coronary artery disease
Atrial fibrillation
High blood pressure
Congenital heart disease
Retinopathy
Neuropathy
Body mass index 35
Ischemia in echocardiography
Disability that causes difficulty in practice.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group: The training group consisted of three sessions per week of high intensity interval training for 4 weeks. Training sessions consisted of 45 minutes walk or running on a treadmill. Each session is divided into 10 minutes of warming up with an intensity 50-70% HRR, 10 minutes of cooling down with an intensity 50-70% HRR  and 25 minutes of high intensity interval training ( HIIT The training section consists of 4 4-minute sections, with an intensity of 85 to 95% HRR and 3-minute rest periods, with an intensity of 50-70% HRR).</i_keyword>
      <i_keyword>Spirulina 2 grams daily, including 4 pills 500 mg before meals, for 4 weeks. This supplement is made by Qeshm algae and contains spirulina pure green algae. spirulina is a blue-green wonder aglae. It is the most powerful food existing in nature with 60% protein content and 18 amino acids.</i_keyword>
      <i_keyword>Third intervention group: Exercise + supplement group consisting of three sessions per week of high intensity interval training for 4 weeks and 2 grams of supplementation of spirulina per day for 4 weeks</i_keyword>
      <i_keyword>fourth intervention group:  control group, No Spirulina supplement and no exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of Malondialdehyde in women with type 2 diabetes. Timepoint: One day before the session begins and 48 hours after the end of the exercise. Method of measurement: The MDA level measurement will be performed by ELISA, using a commercially available chemical calorimetry laboratory kit (MDA test kit; ZellBio GmbH, Ulm, Germany).</prim_outcome>
      <prim_outcome>Serum Total Antioxidant Capacity in women with type 2 diabetes. Timepoint: One day before the session begins and 48 hours after the end of the exercise. Method of measurement: The serum level of antioxidant total capacity will be measured by ELISA and using a commercial kit under the manufacturer's protocols (ZellBio GmbH, Germany).</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>Shahroud University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-02</approval_date>
        <contact_name>Ethics Committee on Biomedical Research of Shahroud University of Medical Sciences.</contact_name>
        <contact_address>Shahrood University of Technology, Haft-e-Tir Square shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
