<?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>IRCT20110527006611N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-17</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Two Months of Cyclic Yoga Exercise on Type 2 Diabetes Patients with Non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Two Months of Cyclic Yoga Exercise on Glycemic Indices, Liver Enzymes and Anthropometric Indices in Type 2 Diabetes Patients with Non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63262</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Type 2 Diabetes. Condition 2: Non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Yoga exercise group: This group  performed cyclic yoga exercise for two months, three days a week. Cyclic Yoga is the art of sequencing yoga asana, pranayama and mudra techniques to maximize their benefits and energize the mind and body.The program of selected cyclic yoga exercises includes stretching exercises for large and small pectoral muscles, internal rotators of the arm, glutes, hamstrings, and strengthening the trapezius and  rhomboid muscles and the external rotators of the arm and the central muscles of the body were performed in the style of cyclic yoga. Intervention 2: Control group: The control group does not participate in any regular exercise activities during the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The study will start after obtaining the informed consent form of the patients and obtaining the code of ethics and permission of the University of Medical Sciences. After the completion of the study, the data will be collected and analyzed, and the final results will be made available to the researchers and relevant authorities based on the approval of the ethics committee and in accordance with the ethical standards based on the format of the university research department without mentioning the names of the participants. The final result will be presented to the university in the form of a final project report.

When:
Start of the 8 month period after the research

To whom:
For university students and students in research related fields

Conditions:
There are no specific conditions to provide such information

Where to obtain:
Zahra Bayat
Email: z.bayat@ut.ac.ir

How to obtain:
Send message to the person responsible for providing the data
Email: z.bayat@ut.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mersad Gym, Sangar Crossroad, 22 Bahman, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714649939</zip>
        <telephone>+98 83 3838 3184</telephone>
        <email>z.bayat@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Houshang Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Blvd, Kermanshah University of Medical Sciences, Kermanshah City</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714869914</zip>
        <telephone>+98 918 836 2982</telephone>
        <email>hnemati@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetic women  with Non-alcoholic fatty liver disease
Type 2 diabetic women 45 to 55 years old with overweight</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No insulin treatment
No complications of diabetes (neuropathy, nephropathy, retinopathy)
No use of drugs and alcoholic drinks,
Not participating in regular exercise activities
No history of cardiovascular and mental illness
No history of fractures, surgery or joint diseases,
Three times or more Absence in training sessions
Lack of hormone therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Yoga exercise group: This group  performed cyclic yoga exercise for two months, three days a week. Cyclic Yoga is the art of sequencing yoga asana, pranayama and mudra techniques to maximize their benefits and energize the mind and body.The program of selected cyclic yoga exercises includes stretching exercises for large and small pectoral muscles, internal rotators of the arm, glutes, hamstrings, and strengthening the trapezius and  rhomboid muscles and the external rotators of the arm and the central muscles of the body were performed in the style of cyclic yoga.</i_keyword>
      <i_keyword>Control group: The control group does not participate in any regular exercise activities during the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glycosylated Hemoglobin. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with Pishtaz Teb kit.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Fatty liver grade. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Alanine Aminotransferase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>Aspartate Aminotransferase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>Alkaline phosphatase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>LDL Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>HDL Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</sec_outcome>
      <sec_outcome>Insulin Hormone. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test Siemens kit made in America.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Standard tape meter.</sec_outcome>
      <sec_outcome>Blood Pressure. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: brachial digital blood pressure monitor.</sec_outcome>
      <sec_outcome>IGF-1 Hormone. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with DiaSorin kit.</sec_outcome>
      <sec_outcome>Hip Circumference. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Standard tape meter.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-07</approval_date>
        <contact_name>Research Ethics Committees of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti blvd- in front of Imam Ali Hospital Building No. 2 kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
