<?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>IRCT20210811052150N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-28</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>effect of Empagliflozine on the Non-Alchoholic Fatti Liver Disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Empagliflozine on the Non-Alcoholic Fatty Liver Disease in patients with type 2 diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple and for each patient according to labeling initial amounts of the placebo (control group) and Empagliflozine(treatment group),using a randomizednumber chart.these same numbers will be written and sealed,and placed in a box for allocation concealment.The course of treatment for each patient will be selected by choosing the random numbers concealed in the box at the beginning of the study, Blinding description: In this study,blinding will e done for the patients as well aspart of the researchers who have the role of clinical caregivers and outcome assessors by coding packages containing empagliflozin and placebo which are apparently the same.Then these codes will be the number of patients in one envelope,will be cast and chosen randomaly.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Non-Alchoholic Fatty Liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes are under intervention with  Empagliflozine at a dose of 10 and 25 mg based on FBS and HbA1c for 6 months and after 3 and 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and degree of fatty liver they are examined in MRI and ultrasound. Intervention 2: Control group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes under standard diabetes treatment with placebo drug that did not contain empagliflozin based on FBS and HbA1c are monitored for 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and liver grade fat is checked in MRI and ultrasound.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Shojaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Loghman Hakim Hospital,Makhsus Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333625445</zip>
        <telephone>+98 21 5541 9005</telephone>
        <email>fateme.shojai@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Loghman Hakim Hospital,Makhsus Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333625445</zip>
        <telephone>+98 21 5541 9005</telephone>
        <email>Fateme.shojai@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozine
No history of using Empaglifozine
GFR&gt;35ml/min/1.7m2
HbA1c≤7.5%
Satisfaction of patients or their legal guardians to attend the study and continue it</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of advanced liver and kidney disease
Cardiac surgery or angioplasty planned within the last 3 months
Bariatric surgery in last 2 years and other gastrointestinal surgeries that cause chronic malabsorotion
Bleeding or any disorder in causing hemolysis or unstable red blood cells(such as malaria)
Medical history of cancer(except basal cell cancer)or cancer treatment in the last 5 years
treatment with anti-obesity drugs in the 3 months prior ti informed consent or any other treatment at the time of screening(i.e. surgery;aggressive dieting;etc)that results in an unstable body weight
current treatment with systemic steroids or any uncontrolled endocrine disorder other than type 2 diabetes
cinsumtion of alcohol or drugs in the last 3 months
patients who during the treatment,another drug to control blood sugar was added to their teatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K75.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic steatohepatitis (NASH)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes are under intervention with  Empagliflozine at a dose of 10 and 25 mg based on FBS and HbA1c for 6 months and after 3 and 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and degree of fatty liver they are examined in MRI and ultrasound.</i_keyword>
      <i_keyword>Control group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes under standard diabetes treatment with placebo drug that did not contain empagliflozin based on FBS and HbA1c are monitored for 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and liver grade fat is checked in MRI and ultrasound</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of fatty liver in MRI. Timepoint: Before treatment  and six months after treatment. Method of measurement: MRI.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: before and three and six monthns after treatment. Method of measurement: Kg/m2.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: before and three and six months after treatmen. Method of measurement: blood sampling.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: before and three and six months after teatment. Method of measurement: blood sampling.</prim_outcome>
      <prim_outcome>The level of liver transaminases. Timepoint: before and three and six months after treatmenet. Method of measurement: blood sampling.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-10</approval_date>
        <contact_name>Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Makhsus avenu Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
