<?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>IRCT20140415017288N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>high-intensity interval training and aloe vera supplementation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a high-intensity interval training and aloe vera supplementation on some plasma adipokines in type 2 diabetic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57340</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size, they will be equally divided into 4groups (1- Control, 2- Exercise, 3- supplementation and 4-  Exercise + supplementation ). Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention groups or placebo, respectively, Blinding description: Each capsule will contain 100 mg of aloe vera gel powder, and each subject will receive one capsule in the morning immediately after waking up and one capsule after dinner, and the control and exercise groups will receive the same amount of placebo. Starch is used as a placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Control group: (in this group we have not any intervention during 12 weeks, and will consider this group as placebo). Intervention 2: Intervention group: High Intensity Periodic Exercise Group (Training protocol of up to 60 cycles per 20-minute session (including 8 seconds of fast pedaling (about 80% of maximum heart rate (HRmax)) followed by gentle pedaling (20-30 rpm) for 12 seconds , To facilitate acceleration and limit the stagnation of the bicycle wheel, the selected resistance will be very low (almost zero). Intervention 3: Intervention group: Aloe vera supplement group Each capsule will contain 100 mg of aloe vera gel powder, and each subject will receive one capsule in the morning immediately after waking up and one capsule after dinner. Intervention 4: Intervention group: High Intensity Periodic Exercise Group - Aloe Vera Supplement (In this group the Simultaneous intervention, aloe vera gel and training, will treat with the same protocol that describe at the previous part).</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:
The report is submitted to the research department of the university. Also published as a paper

When:
Since 2021

To whom:
All researchers

Conditions:
Citing references

Where to obtain:
Scientific bases and Ayatollah Amoli Branch, Islamic Azad University, amol, Iran

How to obtain:
Maximum one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Amoli Branch, Islamic Azad University</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>461671618</zip>
        <telephone>+98 11 4321 7126</telephone>
        <email>A.abdi@iauamol.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Barari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Amoli Branch, Islamic Azad University</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4616716187</zip>
        <telephone>+98 11 4321 7126</telephone>
        <email>Alireza54.barari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes (people with a history of more than twice the fasting glucose above 126 mg / dL with HbA1c above 6.5% and under the supervision of a physician at the time of the study) . Subjects were asked to complete a questionnaire of readiness to start sports.
Lack of cardiovascular
Lack of musculoskeletal
Lack of metabolic diseases limited exercise
lack of high blood pressure
lack of a history of regular exercise during the past six months
lack of insulin</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Use of drugs that lower blood pressure and blood lipids
Exclusion criteria included a history of serious diabetic complications (such as proliferative diabetic retinopathy, stage 3 or subsequent overt nephropathy, diabetic ketoacidosis or severe diabetic neuropathy)
fasting glucose above 270 mg / dL
malaise Hereditary absorption of glucose and galactose or renal glycosuria</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>Placebo</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>Control group: (in this group we have not any intervention during 12 weeks, and will consider this group as placebo)</i_keyword>
      <i_keyword>Intervention group: High Intensity Periodic Exercise Group (Training protocol of up to 60 cycles per 20-minute session (including 8 seconds of fast pedaling (about 80% of maximum heart rate (HRmax)) followed by gentle pedaling (20-30 rpm) for 12 seconds , To facilitate acceleration and limit the stagnation of the bicycle wheel, the selected resistance will be very low (almost zero).</i_keyword>
      <i_keyword>Intervention group: Aloe vera supplement group Each capsule will contain 100 mg of aloe vera gel powder, and each subject will receive one capsule in the morning immediately after waking up and one capsule after dinner.</i_keyword>
      <i_keyword>Intervention group: High Intensity Periodic Exercise Group - Aloe Vera Supplement (In this group the Simultaneous intervention, aloe vera gel and training, will treat with the same protocol that describe at the previous part).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Metrenal. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Catspin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-13</approval_date>
        <contact_name>Ethics Committee of Marvdasht Branch of Azad University</contact_name>
        <contact_address>Three kilometers of Persepolis Boulevard, Islamic Azad University of Marvdasht Marvdasht Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
