<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/NCT02261545</url>
  </required_header>
  <id_info>
    <org_study_id>25367</org_study_id>
    <nct_id>NCT02261545</nct_id>
  </id_info>
  <brief_title>The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient</brief_title>
  <official_title>The Effect of n-3 Fatty Acid Supplementation on the Expression of Sirt-1, Adiponectin Receptor 1 (AdipoR1) &amp; Adiponectin Receptor 2 (AdipoR2) Genes of PBMC and Circulatory Levels of Resistin,Monocyte Chemotactic Protein (MCP-1) and Adiponectin of type2 Diabetes Patient</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 determine the effects of supplementation with n-3 fatty acid or&#xD;
      placebo for 10 weeks on the expression of Sirt-1, AdipoR1 &amp; AdipoR2 genes in the peripheral&#xD;
      blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of&#xD;
      type2 diabetes patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to determine of the effects of supplementation with n-3 fatty acid&#xD;
      or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) &amp;&#xD;
      AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and&#xD;
      circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of&#xD;
      type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled,&#xD;
      88 men and women 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 , 24-hour food recall for 3 days and beck depression questionnaire will be taken from&#xD;
      the participants at the beginning and the end of the study. Selected samples are randomly&#xD;
      classified into 2 blocks of groups receiving supplement and placebo. The supplement group,&#xD;
      will receive mg 1800mg EPA(Eicosapentaenoic acid ) &amp; 900mg DHA( docosahexaenoic acid)&#xD;
      (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700&#xD;
      mg of edible paraffin) (similar in terms of color, shape and size). Patients are recommended&#xD;
      to sustain their diets and medication dose (s) during the study and also advised to maintain&#xD;
      a constant level of physical activity. Blood samples will be collected after 12 hours fasting&#xD;
      and anthropometric variables, biochemical parameters, target gene expression and physical&#xD;
      activity before and after the trial will be measured&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Fasting Blood Sugar(FBS)</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Insulin</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum HbA1C</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Resistin</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum adiponectin</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum mcp-1</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene Expression of AdipoR1</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene Expression of AdipoR2</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene Expression of Sirt-1</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck depression score</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cholesterol</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum LDL cholesterol</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum TG</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum HDL cholesterol</measure>
    <time_frame>Change from baseline at 10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Diabetes Mellitus Type II</condition>
  <arm_group>
    <arm_group_label>n-3 Fatty Acid Supplemetation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>n-3 Fatty Acid</intervention_name>
    <description>n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.</description>
    <arm_group_label>n-3 Fatty Acid Supplemetation</arm_group_label>
    <other_name>omega-3</other_name>
    <other_name>n-3 PUFA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willingness to participation,&#xD;
&#xD;
          -  diabetic patients 30- 60 years old,&#xD;
&#xD;
          -  body mass index in the range 25-40,&#xD;
&#xD;
          -  avoidance of dietary supplements,&#xD;
&#xD;
          -  vitamins and herbal products at least 3 months before and throughout the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people who have used n-3 Fatty Acid Supplementation in last 3 months,&#xD;
&#xD;
          -  having chronic renal disease ,&#xD;
&#xD;
          -  GI disease,&#xD;
&#xD;
          -  Hepatobiliary diseases,&#xD;
&#xD;
          -  hematological disorders,&#xD;
&#xD;
          -  hypo- or hyperthyroidism,&#xD;
&#xD;
          -  type 1 diabetes,&#xD;
&#xD;
          -  treatment with orlistat or sibutramine for weight loss,&#xD;
&#xD;
          -  pregnancy and lactation,&#xD;
&#xD;
          -  treatment with insulin or Thiazolidinediones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>November 17, 2015</last_update_submitted>
  <last_update_submitted_qc>November 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>n-3 fatty acid</keyword>
  <keyword>Sirt-1</keyword>
  <keyword>AdipoR1</keyword>
  <keyword>AdipoR2</keyword>
  <keyword>MCP-1</keyword>
  <keyword>Adiponectin</keyword>
  <keyword>Resistin</keyword>
  <keyword>T2DM</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>
  </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/NCT02261545
org study id: 25367
nct id: NCT02261545
lead sponsor: 
has dmc: Yes
The aim of this study is to determine the effects of supplementation with n-3 fatty acid or
      placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral
      blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of
      type2 diabetes patient
The aim of this study is to determine of the effects of supplementation with n-3 fatty acid
      or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) &
      AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and
      circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of
      type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled,
      88 men and women 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 , 24-hour food recall for 3 days and beck depression questionnaire 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. The supplement group,
      will receive mg 1800mg EPA(Eicosapentaenoic acid ) & 900mg DHA( docosahexaenoic acid)
      (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700
      mg 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 12 hours fasting
      and anthropometric 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: Supportive Care
masking: Double (Participant, Care Provider)
measure: Serum Fasting Blood Sugar(FBS)
time frame: Change from baseline at 10 weeks
measure: Serum Insulin
time frame: Change from baseline at 10 weeks
measure: Serum HbA1C
time frame: Change from baseline at 10 weeks
measure: Serum Resistin
time frame: Change from baseline at 10 weeks
measure: Serum adiponectin
time frame: Change from baseline at 10 weeks
measure: Serum mcp-1
time frame: Change from baseline at 10 weeks
measure: Gene Expression of AdipoR1
time frame: Change from baseline at 10 weeks
measure: Gene Expression of AdipoR2
time frame: Change from baseline at 10 weeks
measure: Gene Expression of Sirt-1
time frame: Change from baseline at 10 weeks
measure: Beck depression score
time frame: Change from baseline at 10 weeks
measure: Serum cholesterol
time frame: Change from baseline at 10 weeks
measure: Serum LDL cholesterol
time frame: Change from baseline at 10 weeks
measure: Serum TG
time frame: Change from baseline at 10 weeks
measure: Serum HDL cholesterol
time frame: Change from baseline at 10 weeks
arm group label: n-3 Fatty Acid Supplemetation
arm group type: Active Comparator
description: patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
intervention type: Dietary Supplement
intervention name: n-3 Fatty Acid
description: n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
arm group label: n-3 Fatty Acid Supplemetation
other name: omega-3
other name: n-3 PUFA
intervention type: Dietary Supplement
intervention name: Placebo
description: 3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2