<?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>IRCT20140415017288N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Exercise and Cinnamon on Diabetic Women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Different Intensities of Aerobic Exercise Combined with Resistance Exercise and Cinnamon Consumption on Meteorin-like protein (Metrnl), Irisin and Inflammatory Factors in Diabetic Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77850</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 6 groups (Control, moderate-intensity aerobic training + resistance training, high-intensity aerobic training + resistance training, cinnamon, moderate-intensity aerobic training + resistance training + cinnamon and high-intensity aerobic training + resistance training + cinnamon). 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 500 mg of cinnamon powder, and each subject will receive one capsule in the morning immediately after breakfast and one capsule after lunch, 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: Intervention group 1: We will consider this group as the control group. Intervention 2: Intervention group 2: Moderate-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 50% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal). Intervention 3: Intervention group 3: High-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 80% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal). Intervention 4: Intervention group 4: Cinnamon supplementation group (in this group eat 1000 mg of cinnamon supplementation for eight weeks Twice a day after breakfast and lunch). Intervention 5: Intervention group 5: Moderate-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, moderate-intensity aerobic training+resistance training+cinnamon, will treat with the same protocol that describe at the previous part). Intervention 6: Intervention group 6: High-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, high-intensity aerobic training+resistance training+cinnamon, 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 2025

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.
Age range in the range of 35-50 years.
Inactive lifestyle (exercise less than 1 hour per week).
Consent to participate in the study.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</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.
Detection of other underlying diseases during the implementation of the protocol, such as cardiopulmonary problems and musculoskeletal disorders during exercise that prevent the performance of the activity.</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>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: We will consider this group as the control group.</i_keyword>
      <i_keyword>Intervention group 2: Moderate-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 50% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal).</i_keyword>
      <i_keyword>Intervention group 3: High-intensity aerobic training+resistance training group (In this group, for 8 weeks, five session/weeks, the training start with 10 minutes of warm-up. Aerobic exercise with an intensity of 80% VO2max is performed along with TRX exercise. The total energy of exercise is about 400 kcal).</i_keyword>
      <i_keyword>Intervention group 4: Cinnamon supplementation group (in this group eat 1000 mg of cinnamon supplementation for eight weeks Twice a day after breakfast and lunch)</i_keyword>
      <i_keyword>Intervention group 5: Moderate-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, moderate-intensity aerobic training+resistance training+cinnamon, will treat with the same protocol that describe at the previous part).</i_keyword>
      <i_keyword>Intervention group 6: High-intensity aerobic training+resistance training+cinnamon group (In this group the Simultaneous intervention, high-intensity aerobic training+resistance training+cinnamon, will treat with the same protocol that describe at the previous part).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on Metrnl. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on Irisin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on PGC-1α. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on TNF-α. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on TGF-β. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on IL-2. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods.</prim_outcome>
      <prim_outcome>Effect of training and cinnamon supplementation on IL-10. 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>2024-07-12</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - Ayatollah Amoli Branch</contact_name>
        <contact_address>Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road. Amol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
