<?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>IRCT20191210045690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-31</date_registration>
      <primary_sponsor>Zand Institute of Higher Education</primary_sponsor>
      <public_title>The Effects of EMS and HIFT on FTO gene expression and metabolic functions</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effects of two training methods: electrical muscle stimulation (EMS) and high-intensity functional training (HIFT) on FTO gene expression and metabolic functions in obese men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92328</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple Randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>FTO gene expression and metabolic functions.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: Control group:.</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 Individual participant data will not be shared due to the need to protect participants’ confidentiality and privacy and to prevent potential identification of individual participants. Sharing individual-level data may also be inconsistent with ethical requirements and the scope of informed consent obtained from the participants. The study results will be reported and published in an aggregated form without any identifiable participant information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Homa Sheikhani Shahin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 12, Iman South Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7188773489</zip>
        <telephone>+98 71 3632 1041</telephone>
        <email>hsheikhani@yahoo.com</email>
        <affiliation>Zand Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Sheikhani Shahin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 12, Iman South Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7188773489</zip>
        <telephone>+98 71 3632 1041</telephone>
        <email>hsheikhani@yahoo.com</email>
        <affiliation>Zand Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body Mass Index between 30 and 35 kg/m², No history of cardiovascular disease, renal failure, liver failure, or asthma, No musculoskeletal abnormalities, No history of surgery, No use of any supplements or medications, No history of regular participation in exercise training for at least 6 months prior to the start of the study, No tobacco use or alcohol consumption</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FTO gene expression. Timepoint: Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training. Method of measurement: Real Time-PCR.</prim_outcome>
      <prim_outcome>Serum Leptin. Timepoint: Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training. Method of measurement: ELISA (Enzyme-Linked Immunosorbent Assay).</prim_outcome>
      <prim_outcome>Fasting Plasma Glucose. Timepoint: Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training. Method of measurement: Glucose oxidase enzymatic method.</prim_outcome>
      <prim_outcome>Serum Insulin. Timepoint: Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training. Method of measurement: Radioimmunoassay.</prim_outcome>
      <prim_outcome>Insulin Resistance. Timepoint: Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training. Method of measurement: Homeostatic model assessment of insulin resistance.</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>Zand Institute of Higher Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-21</approval_date>
        <contact_name>Ethics committee of Shiraz University</contact_name>
        <contact_address>Republic of Islamic Boulevard Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
