<?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>IRCT201112036027N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-18</date_registration>
      <primary_sponsor>Tehran University of Medical sciences</primary_sponsor>
      <public_title>The effect of Topiramate on weight loss in Iranian patients with diabetes type 2</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Topiramate on weight loss in Iranian patients with diabetes type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: The 3-week titration phase began with administration of 25mg topiramate once every morning to subjects assigned to that group. In the second week, topiramate was administered at 25mg twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study. Intervention 2: Control:The 3-week titration phase began with administration of 25mg placebo tablet( prduced by Arya pharmacy company) that had shape and cover similar to topiramate tablets once every morning to subjects assigned to this group. In the second week, placebo tablet was administered at 25mg twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. During the maintenance phase, the dose remained constant . Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study.</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>Sedighe Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Endocrine and metabolism Research center, Firouzgar  hospital,Valiasr sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2620 2448</telephone>
        <email>s-moradi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Endocrine and metabolism Research center, Firouzgar  hospital,Valiasr sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2620 2448</telephone>
        <email>s-moradi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- patients aged 18–75 years 2-body mass index (BMI) between 27 and 50 kg/m2 3-documented history of type 2 diabetes mellitus 4- glycosylated hemoglobin (HbA1c) less than 11%  5- blood pressure (BP) less than 160/105 mmHg 6-constant weight for at least 3 months (±3 kg). Exclusion criteria: 1-History of central nervous system (CNS) related or psychiatric disorders 2-Significant renal, hepatic or thyroid disease 3- Pregnancy 4- Sever diabetes complications</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: The 3-week titration phase began with administration of 25mg topiramate once every morning to subjects assigned to that group. In the second week, topiramate was administered at 25mg twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study.</i_keyword>
      <i_keyword>Control:The 3-week titration phase began with administration of 25mg placebo tablet( prduced by Arya pharmacy company) that had shape and cover similar to topiramate tablets once every morning to subjects assigned to this group. In the second week, placebo tablet was administered at 25mg twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. During the maintenance phase, the dose remained constant . Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percent change in body weight. Timepoint: End of the study. Method of measurement: Body mass index measurment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in systolic and Diastolic blood pressure. Timepoint: At the end of study. Method of measurement: Blood pressure measurment.</sec_outcome>
      <sec_outcome>Changes in glycosylated hemoglobin (HgA1c). Timepoint: At the end of study. Method of measurement: HbA1C measurment.</sec_outcome>
      <sec_outcome>Changes in lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides). Timepoint: At the end of study. Method of measurement: Lipid profile measurment.</sec_outcome>
      <sec_outcome>Proportion of subjects who achieved  5% or 10% weight loss (5% and 10% weight responders). Timepoint: At the end of study. Method of measurement: weight measurment with standadrd method.</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>Tehran University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-08-20</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz BLV, Qods st, Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
