<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03258840</url>
  </required_header>
  <id_info>
    <org_study_id>15202</org_study_id>
    <nct_id>NCT03258840</nct_id>
  </id_info>
  <brief_title>EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus</brief_title>
  <official_title>The Effect of EPA on the Serum Activities of Paraoxonase 1, Homocystein, Thiolactonase and Some Indicators of Vascular Inflammation and PON2 Gene Expression in PBMC Ofthe Patients With Type II Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)&#xD;
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum&#xD;
      levels of some indicators of vascular inflammation, and the gene expression of PON2 in the&#xD;
      peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)&#xD;
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and&#xD;
      several indicators of vascular inflammation and the gene expression of PON2 in the peripheral&#xD;
      blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this&#xD;
      randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women&#xD;
      aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes&#xD;
      Association. After signing informed consent, all individuals complete a general information&#xD;
      form. a 24-hour food recall for 3 days will be taken from the participants at the beginning&#xD;
      and the end of the study,. Selected samples are randomly classified into 2 blocks of groups&#xD;
      receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The&#xD;
      supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also&#xD;
      receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and&#xD;
      size). Patients are recommended to sustain their diets and medication dose (s) during the&#xD;
      study and also advised to maintain a constant level of physical activity. Blood samples will&#xD;
      be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters,&#xD;
      target gene expression and physical activity before and after the trial will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Change from Baseline at 8 weeks after the intervention</time_frame>
    <description>Hemoglobin A1c (HbA1c) measurement by related kits according their protocols</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PON2 gene expression</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Change frome baseline at 8 weeks</time_frame>
    <description>Systolic blood pressure changes measurement by manometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Change frome baseline at 8 weeks</time_frame>
    <description>Diastolic blood pressure changes measurement by manometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum paraoxonase-1(PON-1) activity</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>serum paraoxonase-1(PON-1) activity by kit according related protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PON1/HDL-c Ratio</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum paraoxonase lactonase (PON-HCTLase) activity</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-c</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FBS</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>Fasting blood sugar (FBS) measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL2-c</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL3-c</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum apo B</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>Serum apo-protein B measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum apo A-I</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>Serum apo-protein A-I measurement by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apo B/apo A-I Ratio</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum methionine</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of methionine by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum malondialdehyde (MDA)</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum homocysteine (Hcy)</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of homocysteine (Hcy) by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum sE-Selectin</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of soluble E-Selectin by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sVCAM-1</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cysteine</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of cysteine by related kit according its protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Lpa</measure>
    <time_frame>Baseline, 8 weeks after the intervention</time_frame>
    <description>measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetes Mellitus Type II</condition>
  <arm_group>
    <arm_group_label>EPA placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EPA supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>EPA Supplement</intervention_name>
    <description>EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.</description>
    <arm_group_label>EPA supplement</arm_group_label>
    <other_name>Eicosapentaenoic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>EPA Placebo</intervention_name>
    <description>EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.</description>
    <arm_group_label>EPA placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Willingness to collaborate in the study&#xD;
&#xD;
          -  aged 35-50 years&#xD;
&#xD;
          -  having a history of at least 1 year of type 2 diabetes mellitus before the&#xD;
             participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma&#xD;
             glucose),&#xD;
&#xD;
          -  25≤BMI&lt;30 kg/m2&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  pregnant and breastfeeding women&#xD;
&#xD;
          -  using insulin, alcohol consumption, smoking and other drugs&#xD;
&#xD;
          -  taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin&#xD;
             supplements and ω-3 fatty acid supplements&#xD;
&#xD;
          -  followers of the special diet&#xD;
&#xD;
          -  history of diabetic retinopathy or diabetic nephropathy&#xD;
&#xD;
          -  type 1 diabetes mellitus and other disorders&#xD;
&#xD;
          -  any need to take insulin, change in the dose (s) and type of medication or physical&#xD;
             activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Hassan Golzari, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition &amp; Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmoud Djallali, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Nutrition &amp; Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saeed Hosseini, MD,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Department of Nutrition &amp; Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition</name>
      <address>
        <city>Tehran</city>
        <zip>1471613151</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2011</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EPA</keyword>
  <keyword>Paraoxonase 1</keyword>
  <keyword>Paraoxonase 2</keyword>
  <keyword>Type 2 diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258840
org study id: 15202
nct id: NCT03258840
lead sponsor: 
has dmc: Yes
The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum
      levels of some indicators of vascular inflammation, and the gene expression of PON2 in the
      peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.
The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)
      supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and
      several indicators of vascular inflammation and the gene expression of PON2 in the peripheral
      blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this
      randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women
      aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes
      Association. After signing informed consent, all individuals complete a general information
      form. a 24-hour food recall for 3 days will be taken from the participants at the beginning
      and the end of the study,. Selected samples are randomly classified into 2 blocks of groups
      receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The
      supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also
      receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and
      size). Patients are recommended to sustain their diets and medication dose (s) during the
      study and also advised to maintain a constant level of physical activity. Blood samples will
      be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters,
      target gene expression and physical activity before and after the trial will be measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: HbA1c
time frame: Change from Baseline at 8 weeks after the intervention
description: Hemoglobin A1c (HbA1c) measurement by related kits according their protocols
measure: PON2 gene expression
time frame: Baseline, 8 weeks after the intervention
description: measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR
measure: Systolic blood pressure
time frame: Change frome baseline at 8 weeks
description: Systolic blood pressure changes measurement by manometer
measure: Diastolic blood pressure
time frame: Change frome baseline at 8 weeks
description: Diastolic blood pressure changes measurement by manometer
measure: serum paraoxonase-1(PON-1) activity
time frame: Baseline, 8 weeks after the intervention
description: serum paraoxonase-1(PON-1) activity by kit according related protocol
measure: PON1/HDL-c Ratio
time frame: Baseline, 8 weeks after the intervention
description: calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols
measure: serum paraoxonase lactonase (PON-HCTLase) activity
time frame: Baseline, 8 weeks after the intervention
description: measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol
measure: HDL-c
time frame: Baseline, 8 weeks after the intervention
description: high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols
measure: FBS
time frame: Baseline, 8 weeks after the intervention
description: Fasting blood sugar (FBS) measurement by related kits according their protocols
measure: HDL2-c
time frame: Baseline, 8 weeks after the intervention
description: high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols
measure: HDL3-c
time frame: Baseline, 8 weeks after the intervention
description: high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols
measure: Serum apo B
time frame: Baseline, 8 weeks after the intervention
description: Serum apo-protein B measurement by related kits according their protocols
measure: Serum apo A-I
time frame: Baseline, 8 weeks after the intervention
description: Serum apo-protein A-I measurement by related kits according their protocols
measure: apo B/apo A-I Ratio
time frame: Baseline, 8 weeks after the intervention
description: calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols
measure: Serum methionine
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of methionine by related kit according its protocol
measure: Serum malondialdehyde (MDA)
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol
measure: Serum homocysteine (Hcy)
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of homocysteine (Hcy) by related kit according its protocol
measure: Serum sE-Selectin
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of soluble E-Selectin by related kit according its protocol
measure: sVCAM-1
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol
measure: Serum cysteine
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of cysteine by related kit according its protocol
measure: Serum Lpa
time frame: Baseline, 8 weeks after the intervention
description: measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol
arm group label: EPA placebo
arm group type: Placebo Comparator
description: EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks
arm group label: EPA supplement
arm group type: Active Comparator
description: EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.
intervention type: Dietary Supplement
intervention name: EPA Supplement
description: EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
arm group label: EPA supplement
other name: Eicosapentaenoic acid
intervention type: Dietary Supplement
intervention name: EPA Placebo
description: EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
arm group label: EPA placebo
criteria: 
gender: All
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mohammad Hassan Golzari, Ph.D
role: Principal Investigator
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
last name: Mahmoud Djallali, Ph.D
role: Study Chair
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
last name: Saeed Hosseini, MD,Ph.D
role: Study Director
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Inflammation