<?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>IRCT2017050833869N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-29</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of 12 Weeks Aerobic, Resistance and Combined Exercises on Omentin-1 Levels and Insulin Resistance among Type 2 Diabetic Middle-Aged Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of 12 Weeks Aerobic, Resistance and Combined Exercises on Omentin-1 Levels and Insulin Resistance among Type 2 Diabetic Middle-Aged Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: All volunteers were examined by a general physician to assure that the intervention would not endanger patients. All participants gave their written informed consent. Group assignment: patients were divided into four groups each consisting of 15 participants. A group (control group) received no intervention and three groups underwent ‘AEs,’ ‘REs,’ group, and ‘CEs’ groups. &#13;
For those in AE group, each exercise session consisted of three phases of warm up, the main stage and a cool-down period. The warm-up phase comprised of 20 minutes of stretching and jogging. The main phase of the study was consisted of 25 minutes exercise in order to achieve 50% to 55% of maximum heart rate as measured by cycle ergo-meter. Running, exercise and stretching made up the cooling-down phase. Intervention 2: Each phase in the RE group had three sessions per week which consisted of three phases of warm-up, the main, and cooling-down. The warm-up involved 20 minutes of stretching exercises and jogging on the spot. The main phase consisted of three sets×eight repetitions of weight training including leg extension, prone leg curl, abdominal crunch, biceps, triceps, and seated calf. The exercise intensity was 50% to 55% of one repetition maximum or 1 repetition maximum (RM). The cooling-down also consisted of running, free exercises and stretching. Intervention 3: The group with CEs had the same schedule of other groups for warm-up and cooling-down. The main phase consisted of aerobic training integrated with RE, with half the execution time and the same intensity of resistance and aerobic groups. The trainings programs were performed within three sessions per week for 12 weeks. Every 2 weeks, in all exercise groups training was increased by 5 minutes and the intensity by 5%. The average intensity of main stage in every exercise group was 5.5 metabolic equivalent of task (MET) in first week and increased to 7.1 MET at the end of the study. Intervention 4: control group received no intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Dianati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 841 3762</telephone>
        <email>dianatinasab@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Fararouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 310 6583</telephone>
        <email>fararooei@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria were: having been suffering from T2DM (fasting blood sugar ≥126 mg/dl and 2-hour postprandial blood glucose ≥200 mg/dl) for at least 2 years; being female; aged 45 to 60 years exclusion criteria: diagnosed with any other diseases</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All volunteers were examined by a general physician to assure that the intervention would not endanger patients. All participants gave their written informed consent. Group assignment: patients were divided into four groups each consisting of 15 participants. A group (control group) received no intervention and three groups underwent ‘AEs,’ ‘REs,’ group, and ‘CEs’ groups. &#13;
For those in AE group, each exercise session consisted of three phases of warm up, the main stage and a cool-down period. The warm-up phase comprised of 20 minutes of stretching and jogging. The main phase of the study was consisted of 25 minutes exercise in order to achieve 50% to 55% of maximum heart rate as measured by cycle ergo-meter. Running, exercise and stretching made up the cooling-down phase.</i_keyword>
      <i_keyword>Each phase in the RE group had three sessions per week which consisted of three phases of warm-up, the main, and cooling-down. The warm-up involved 20 minutes of stretching exercises and jogging on the spot. The main phase consisted of three sets×eight repetitions of weight training including leg extension, prone leg curl, abdominal crunch, biceps, triceps, and seated calf. The exercise intensity was 50% to 55% of one repetition maximum or 1 repetition maximum (RM). The cooling-down also consisted of running, free exercises and stretching.</i_keyword>
      <i_keyword>The group with CEs had the same schedule of other groups for warm-up and cooling-down. The main phase consisted of aerobic training integrated with RE, with half the execution time and the same intensity of resistance and aerobic groups. The trainings programs were performed within three sessions per week for 12 weeks. Every 2 weeks, in all exercise groups training was increased by 5 minutes and the intensity by 5%. The average intensity of main stage in every exercise group was 5.5 metabolic equivalent of task (MET) in first week and increased to 7.1 MET at the end of the study.</i_keyword>
      <i_keyword>control group received no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insulin Resistance. Timepoint: At 2 stage. First day of the study (before any intervention) and second mesure after 12 weeks intervention. Method of measurement: اندازه گیری با اسفاده از کیت انسولین و فرمول روبرو: Insulin resistance =[fasting glucose (mg/dL)×fasting insulin (mU/L)/405].</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Before intervention, 5 mL blood samples were taken after 12 hours of fasting and the serum samples were separated using a centrifuge. The samples were frozen at –70° degrees centigrade until the time of serum analysis and omentin-1 and plasma glucose were then measured. Serum omentin-1 and fasting insulin concentrations were determined using enzyme-linked immunosorbent assay kits (Cristal day biotech, Shanghai, China) and (Monobind, Aachen, Germany). Fasting plasma glucose was measured using glucose kit (Pars Azmoon, Tehran, Iran) through the photometric method. Insulin resistance was determined through homeostasis model evaluation (HOMA-IR) and based on the following equation: HOMA-IR=[fasting glucose (mg/dL)×fasting insulin (mU/L)/405]. Timepoint: before intervention, 5 mL blood samples were taken after 12 hours of fasting and the serum samples were separated using a centrifuge. The samples were frozen at –70° degrees centigrade until the time of serum analysis and omentin-1 and plasma glucose were then measured. Serum omentin-1 and fasting insulin concentrations were determined using enzyme-linked immunosorbent assay kits (Cristal day biotech, Shanghai, China) and (Monobind, Aachen, Germany). Fasting plasma glucose was measured using glucose kit (Pars Azmoon, Tehran, Iran) through the photometric method. Insulin resistance was determined through homeostasis model evaluation (HOMA-IR) and based on the following equation: HOMA-IR=[fasting glucose (mg/dL)×fasting insulin (mU/L)/405]. Method of measurement: before intervention, 5 mL blood samples were taken after 12 hours of fasting and the serum samples were separated using a centrifuge. The samples were frozen at –70° degrees centigrade until the time of serum analysis and omentin-1 and plasma glucose were then measured. Serum omentin-1 and fasting insulin concentrations were determined using enzyme-linked immunosorbent assay kits (Cristal day biotech, Shanghai, China) and (Monobind, Aachen, Germany). Fasting plasma glucose was measured using glucose kit (Pars Azmoon, Tehran, Iran) through the photometric method. Insulin resistance was determined through homeostasis model evaluation (HOMA-IR) and based on the following equation: HOMA-IR=[fasting glucose (mg/dL)×fasting insulin (mU/L)/405].</sec_outcome>
      <sec_outcome>Change in plasma omentin-1. Timepoint: before and after interventiond. Method of measurement: before intervention, 5 mL blood samples were taken after 12 hours of fasting and the serum samples were separated using a centrifuge. The samples were frozen at –70° degrees centigrade until the time of serum analysis and omentin-1 and plasma glucose were then measured. Serum omentin-1 and fasting insulin concentrations were determined using enzyme-linked immunosorbent assay kits (Cristal day biotech, Shanghai, China) and (Monobind, Aachen, Germany). Fasting plasma glucose was measured using glucose kit (Pars Azmoon, Tehran, Iran) through the photometric method. Insulin resistance was determined through homeostasis model evaluation (HOMA-IR) and based on the following equation: HOMA-IR=[fasting glucose (mg/dL)×fasting insulin (mU/L)/405].</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-22</approval_date>
        <contact_name>Shiraz University of Medical Sciences ethical comity</contact_name>
        <contact_address>Shiraz University of Medical Sciences Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
