<?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>IRCT20090609002017N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-06</date_registration>
      <primary_sponsor>Nutrition Research Center, Tabriz University of Medical Science</primary_sponsor>
      <public_title>Effect of sodium butyrate in prevention and treatment of type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sodium butyrate supplementation on serum oxidative stress indices and gene expression level of  pyroptosis related inflammatory factors in type 2 diabetic patients: A randomized, double-blind, placebo-controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be assigned to intervention and control groups by random blocking, Blinding description: In this study, investigator and participants will be unaware of the type of supplementation (sodium butyrate or placebo).The person responsible for the preparation of capsules' packs (a person completely unrelated to the study) will be asked to assign a code to each of the two packages (sodium butyrate and placebo), and to keep the codes up to the end of the study and data analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetes mellitus Type 2.</hc_freetext>
      <i_freetext>Intervention 1: Group 1 will receive sodium butyrate capsules (BodyBio) for 6 weeks at a daily dose of 600 mg in the form of capsules of 100 mg with meals. Intervention 2: Control group: Group 2 will use starch capsule as placebo for 6 weeks at a daily dose of 6 capsule with meals.</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:
Individual participant data that underlie the outcomes reported in this article, after deidentification (text, tables, figures, and appendices),Study Protocol, Statistical Analysis Plan, Clinical Study Report

When:
Beginning 6 months and ending 2 years following article publication

To whom:
Researchers who provide a methodologically sound proposal.

Conditions:
The datasets are available from the corresponding author on reasonable request and to achieve aims in the approved proposal.

Where to obtain:
Proposals should be directed to corresponding author.

How to obtain:
All data requests should be submitted to the corresponding author for consideration. To gain access, data requestors will need to sign a data access agreement.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition, Tabriz University of Medical Science, Attar Neyshaburi st., Golgasht ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>z.khosravi71@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Ostadrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition, Tabriz University of Medical Science, Attar Neyshaburi st., Golgasht ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 2295</telephone>
        <email>ostadrahimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Ages between 30 to 50 years (both sexes)
Diagnosis of type 2 diabetes
Body mass index (BMI) between 27 to 35 kg/m2
People who control their diabetes just by using blood glucose lowering tablets.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Chronic diseases such as cardiovascular disorders and ...
Kidney, liver and thyroid disorders
Rheumatic Diseases
Inflammatory diseases of the gastrointestinal tract or malabsorption, such as  sprue and crowns
Insulin injection,  taking estrogenic drugs, progesterone &amp; corticosteroids
Taking vitamin supplements; minerals; omega-3 and antibiotics for three weeks before the study
Changes in diet and physical activity
Smoking
Having certain physiological conditions like pregnancy and lactation and menopause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1 will receive sodium butyrate capsules (BodyBio) for 6 weeks at a daily dose of 600 mg in the form of capsules of 100 mg with meals.</i_keyword>
      <i_keyword>Control group: Group 2 will use starch capsule as placebo for 6 weeks at a daily dose of 6 capsule with meals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TLR-4 expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>NLRP3 expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>Caspase-1 expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>ASC expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>IL-1β expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>IL-18 expression. Timepoint: Before &amp; after the intervention. Method of measurement: Real-time PCR.</prim_outcome>
      <prim_outcome>Glutathion Peroxidase (GPx). Timepoint: Before &amp; after the intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Nitric Oxide (NO). Timepoint: Before &amp; after the intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Fasting Blood Glucose. Timepoint: Before &amp; after the intervention. Method of measurement: Enzymatic assay.</prim_outcome>
      <prim_outcome>Fasting Insulin. Timepoint: Before &amp; after the intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: Before &amp; after the intervention. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Before &amp; after the intervention. Method of measurement: HOMA-IR formula: [fasting insulin (µU/ml)*fasting glucose (mg/dL)]/ 405.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before &amp; after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>HDL-Cholesterol. Timepoint: Before &amp; after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Total Cholesterol. Timepoint: Before &amp; after the intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>LDL-Cholesterol. Timepoint: Before &amp; after the intervention. Method of measurement: Friedewald's formula: LDL= TC - [HDL + (TG/5)].</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic Blood Pressure. Timepoint: Before &amp; after the intervention. Method of measurement: Digital barometer.</sec_outcome>
      <sec_outcome>Diastolic Blood Pressure. Timepoint: Before &amp; after the intervention. Method of measurement: Digital barometer.</sec_outcome>
      <sec_outcome>Energy and macro-nutrient intake. Timepoint: Before &amp; after the intervention. Method of measurement: Questionnaire (3 days dietary record).</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before &amp; after the intervention. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before &amp; after the intervention. Method of measurement: BMI formula.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before &amp; after the intervention. Method of measurement: Nonelastic flexible tape.</sec_outcome>
      <sec_outcome>Hip circumferences. Timepoint: Before &amp; after the intervention. Method of measurement: Nonelastic flexible tape.</sec_outcome>
      <sec_outcome>Waist to Hip Ratio (WHR). Timepoint: Before &amp; after the intervention. Method of measurement: Calculation.</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>Nutrition Research Center, Tabriz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-11</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>3rd. Floor, Central Bldg. No.2, Golgasht st., Azadi Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
