<?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>IRCT20180806040721N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-03</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of 8 weeks of different training (aerobic, resistance and combination) on serum levels of nesfatin-1 and insulin resistance index in women with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 8 weeks of different training (aerobic, resistance and combination) on serum levels of nesfatin-1 and insulin resistance index in women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabets.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aerobic training group                                                      Participants of this group performed their activities using treadmill or bicycle  three times per week (on non consecutive days). Time of exercise was increased from 20 minutes per session (at 60% of maximum heart rate) to 60 minutes (at 75% of maximum heart rate) per session. Heart rate was regularly determined by the monitor’s treadmill or cycle ergometers. Required heart rate was calculated by the Karvonen formula. Intervention 2: Intervention group: Resistance training group                                                            This program was performed on different weight machines. Correct training techniques were instructed and supervised by professional trainers. The protocol was started on 2 days of the week during the first month and was increased to 3 non-consecutive days per week. Training was started during weeks 1 and 2 with intensity 60% onerepetition maximum (1RM) and was progressed to intensity 75-80% 1RM. The number of sets was 1-2 during the first month. This program included 10 different exercises for upper and lower body. Participants performed 3 sets of 8-10 repetitions (with a 90- 120 s rest between sets) of the following exercises: bench press, seated row, shoulder press, chest press, lateral pulldown, abdominal crunches, leg press, leg extension, triceps pushdown and seated bicep curls. Intervention 3: Intervention group: Combined training group (aerobic-resistance)                      The subjects of this group did the aerobic exercise plus resistance training programs 3 times a week. After a warm-up stage, they worked for 20-30 minutes on a treadmill or bicycle plus 2 sets of each of 8 exercises with 8-10 repetitions on weight machines. Intervention 4: control group:control group                                                                               A group that did not have any training 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The epidemic is the consent of the participants to disseminate their information and data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dianatinasab Mostafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Street</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71-535121</zip>
        <telephone>+98 23 3223 4521</telephone>
        <email>dianati.epid@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dianatinasab Mostafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Street</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71-535121</zip>
        <telephone>+98 23 3223 4521</telephone>
        <email>dianati.epid@yahoo.com</email>
        <affiliation>Shahroud 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;  old
Women 45 to 60 years</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>exclusion criteria: diagnosed with any other diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aerobic training group                                                      Participants of this group performed their activities using treadmill or bicycle  three times per week (on non consecutive days). Time of exercise was increased from 20 minutes per session (at 60% of maximum heart rate) to 60 minutes (at 75% of maximum heart rate) per session. Heart rate was regularly determined by the monitor’s treadmill or cycle ergometers. Required heart rate was calculated by the Karvonen formula</i_keyword>
      <i_keyword>Intervention group: Resistance training group                                                            This program was performed on different weight machines. Correct training techniques were instructed and supervised by professional trainers. The protocol was started on 2 days of the week during the first month and was increased to 3 non-consecutive days per week. Training was started during weeks 1 and 2 with intensity 60% onerepetition maximum (1RM) and was progressed to intensity 75-80% 1RM. The number of sets was 1-2 during the first month. This program included 10 different exercises for upper and lower body. Participants performed 3 sets of 8-10 repetitions (with a 90- 120 s rest between sets) of the following exercises: bench press, seated row, shoulder press, chest press, lateral pulldown, abdominal crunches, leg press, leg extension, triceps pushdown and seated bicep curls</i_keyword>
      <i_keyword>Intervention group: Combined training group (aerobic-resistance)                      The subjects of this group did the aerobic exercise plus resistance training programs 3 times a week. After a warm-up stage, they worked for 20-30 minutes on a treadmill or bicycle plus 2 sets of each of 8 exercises with 8-10 repetitions on weight machines</i_keyword>
      <i_keyword>control group:control group                                                                               A group that did not have any training intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nesfatin-1. Timepoint: At the beginning of the study (before the intervention) and 2 months after the intervention, it was measured. Method of measurement: The serum level of nesfatin-1 was measured using the Sandwich Elisa method and using the Eastbiopharm human kit / country-China manufacturing.</prim_outcome>
      <prim_outcome>Insulin resistance index. Timepoint: At the beginning of the study (before the intervention) and 2 months after the intervention, it was measured. Method of measurement: Insulin resistance index using formula =                                                     fasting insulin (μU / ml) × fasting glucose (mmol / L)  / 22.5.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glocose/ Insulin- Insulin resistance. Timepoint: At the beginning of the study (before the intervention) and 2 months after the intervention, it was measured. Method of measurement: The glucose level was measured using the Colorimetric Enzymatic method and using the human kit of Iran Pars Tesh T Persian Company.  Insulin levels were measured by Insulin ELISA in the United States.            Insulin resistance with the formula:                                                                      fasting glucose (mmol / L) * fasting insulin (μU / ml)/ 22/5.</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 Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-22</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>Tehran street Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
