<?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>IRCT201211106415N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-02</date_registration>
      <primary_sponsor>Vice chancellor for research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  L-Arginine supplementation on antioxidant status in Pre-diabetic patients .</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  L-Arginine supplementation on antioxidant enzyme activity of Type 2 Pre-diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6850</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pre-diabetic patient.</hc_freetext>
      <i_freetext>Intervention 1: People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g L-arginine (3 capsules containing 1 g L-arginine) was given every 8 hours for 8 weeks.&#13;
At the end of the fourth and eighth weeks remaining capsules were counted, patients did not take their more than 10 percent of capsules, are excluded from the study. The subjects were told not to change diet and activity level. Intervention 2: People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g placebo(3 capsules containing 1 g Maltodextrin that  was similar l-arginine) was given the same as the intervention group. The subjects were told not to change diet and activity level.</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>Siavash Fazelian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Biochemistry group,4th floor,  Health Faculty, Poursina St, 16 Azar St, Keshavarz Blvd St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6640 2095</telephone>
        <email>siavash_nut@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Saedi Some Olia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Biochemistry group,4th floor,  Health Faculty, Poursina St, 16 Azar St, Keshavarz Blvd St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6640 2095</telephone>
        <email>: a_saedi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A) Inclusion criteria:&#13;
 -  tendency to cooperate with research project&#13;
 - Newly diagnosed individuals with pre-diabetes&#13;
 - People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL&#13;
 - Range of BMI 25 to 34.9 Kg / m 2&#13;
 - Age: 20 to 50 years;&#13;
B) Not allowed to inter criteria: - Have not past medical history of chronic diseases such as cardiovascular disease, liver disease, thyroid disease, chronic infection, heart attack or stroke in the previous years .- Taking lipid-lowering drugs, blood sugar-lowering drugs, estrogen or progesterone, antibiotics during past year ,- Taking any supplements such as L - arginine during the 2 months prior to the study- Smoking - pregnancy or lactation, or menopause - alcohol intake;&#13;
C) Exclusion Criteria: - Non-compliance supplements taking (more than 10% of supplements it is not been taken .)&#13;
 - The existence of any of the criteria Not allowed to inter criteria - not wanting to continued cooperation</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impaired glucose tolerancePrediabetes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g L-arginine (3 capsules containing 1 g L-arginine) was given every 8 hours for 8 weeks.&#13;
At the end of the fourth and eighth weeks remaining capsules were counted, patients did not take their more than 10 percent of capsules, are excluded from the study. The subjects were told not to change diet and activity level.</i_keyword>
      <i_keyword>People with pre-diabetes, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL - Range of BMI 25 to 34.9 Kg / m 2 - Age: 20 to 50 years. daily 3 g placebo(3 capsules containing 1 g Maltodextrin that  was similar l-arginine) was given the same as the intervention group. The subjects were told not to change diet and activity level.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glutathione peroxidase activity level. Timepoint: Before and 2 months after the start of supplementation. Method of measurement: Blood testing (by ELISA kit).</prim_outcome>
      <prim_outcome>Glutathione reductase activity. Timepoint: Before and 2 months after the start of supplementation. Method of measurement: Blood testing (by ELISA kit).</prim_outcome>
      <prim_outcome>Superoxide dismutase activity. Timepoint: Before and 2 months after the start of supplementation. Method of measurement: Blood testing (by ELISA kit).</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before and 2 months after the start of supplementation. Method of measurement: Blood testing (by ELISA kit).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum concentrations of arginine. Timepoint: Before and 2 months after supplementation. Method of measurement: blood testing.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before and 2 months after supplementation. Method of measurement: Use Scale With Accuracy 100g.</sec_outcome>
      <sec_outcome>Height. Timepoint: Before and 2 months after supplementation. Method of measurement: Tape mete Installed on the wall.</sec_outcome>
      <sec_outcome>BMI(Body Mass Index). Timepoint: Before and 2 months after supplementation. Method of measurement: Calculation:Weight (kg) / squared height (m).</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before and 2 months after supplementation. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before and 2 months after supplementation. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Waist to Hip ratio. Timepoint: Before and 2 months after supplementation. Method of measurement: Calculation.</sec_outcome>
      <sec_outcome>Energy intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Carbohydrate intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Protein intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Lipid intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Cholesterol intake. Timepoint: befor supplementation. Method of measurement: 24 hours recall.</sec_outcome>
      <sec_outcome>Fiber intake. Timepoint: befor supplementation. Method of measurement: 24hours recall.</sec_outcome>
      <sec_outcome>Saturated fatty acid intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Mono unSaturated fatty acid intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</sec_outcome>
      <sec_outcome>Polyunsaturated fatty acids intake. Timepoint: Before supplementation. Method of measurement: 24 hour recall.</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>Vice chancellor for research,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-03</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Vice chancellor for research,Tehran University of Medical Sciences, Keshavarz Blvd, Ghods st Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
