<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/NCT03008057</url>
  </required_header>
  <id_info>
    <org_study_id>32615</org_study_id>
    <nct_id>NCT03008057</nct_id>
  </id_info>
  <brief_title>The Assessment of the Effect of Vitamin D Supplementation on Inflammatory and Endothelial Factors in the Patients With Type 2 Diabetes .</brief_title>
  <official_title>The Assessment of the Effect of Vitamin D Supplementation on the Serum of AGES and Endothelialy Factors and Gene Expression of Glyoxalase Enzyme and YKL-40 Factor in PBMC Cells in the Patients With Type 2 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 determine the effects of vitamin D or placebo for 3 months on the&#xD;
      gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear&#xD;
      cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the&#xD;
      gene expression of plasma human cartilage glycoprotein 39(YKL40), receptor for advanced&#xD;
      glycation end products (RAGE) and glyoxalase enzyme in the peripheral blood mononuclear cell&#xD;
      (PBMC) and serum levels of YKL40 ,plasminogen activator inhibitor-1 (PAI-1), TNF-α, advanced&#xD;
      glycation end products (AGEs ), IL-6, and HbA1c of diabetes type 2 patients.&#xD;
&#xD;
      In this randomized, double-blind clinical trial, placebo-controlled study, 84 women and men&#xD;
      with type 2 diabetes are enrolled from the Iranian Center of diabetes. At the start of study,&#xD;
      all participants will sign informed consent and complete a general information form. 24-hour&#xD;
      food record for 3 days will be taken from the patients at the beginning and the end of the&#xD;
      study. Selected samples by using stratified randomization method based on sex, gender and&#xD;
      body mass index (BMI) are classified into 2 groups: 1) receiving vitamin D supplement 2)&#xD;
      receiving vitamin D placebo bo.&#xD;
&#xD;
      The vitamin D supplement group will receive 4000 IU (100 microgram) daily for 3 months. The&#xD;
      vitamin D placebo group will also receive placebo containing starch both similar in terms of&#xD;
      color, shape and size. participants are advised to maintain their diet, level of physical&#xD;
      activity and medication dose during the study. Blood samples will be collected after&#xD;
      anthropometric parameter measuring then target biochemical parameters, gene expression and&#xD;
      serum levels and physical activity will be measured before and after the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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 HbA1c</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum fasting insulin</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Fasting blood suger,</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum AGES</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum IL6</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum TNF-alpha</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum PAI-1</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RAGE gene expression</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>YKL40 gene expression</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glyoxalase enzyme gene expression</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum IL-17</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum IL-4</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum Transforming growth factor beta</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum YKL40</measure>
    <time_frame>Change frome baseline at 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>vitamin D supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D</intervention_name>
    <description>vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months</description>
    <arm_group_label>vitamin D supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D placebo</intervention_name>
    <description>vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months</description>
    <arm_group_label>vitamin D placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30&#xD;
        ,literate, willingness to participation,avoidance of dietary supplements, vitamins and&#xD;
        herbal products at least 3 months before and throughout the intervention -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people who have used vitamin D supplements in last 3 months, having chronic renal&#xD;
             disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or&#xD;
             hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and&#xD;
             lactation, treatment with insulin or Thiazolidinediones, Smokers,sever change in&#xD;
             regular diet and life style,change in type and dosage of regular medication (s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>YKL40</keyword>
  <keyword>PAI-1</keyword>
  <keyword>RAGE</keyword>
  <keyword>AGEs</keyword>
  <keyword>glyoxalase enzyme</keyword>
  <keyword>TNF-alpha</keyword>
  <keyword>IL-6</keyword>
  <keyword>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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_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/NCT03008057
org study id: 32615
nct id: NCT03008057
lead sponsor: 
has dmc: Yes
The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the
      gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear
      cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2
      patients.
The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the
      gene expression of plasma human cartilage glycoprotein 39(YKL40), receptor for advanced
      glycation end products (RAGE) and glyoxalase enzyme in the peripheral blood mononuclear cell
      (PBMC) and serum levels of YKL40 ,plasminogen activator inhibitor-1 (PAI-1), TNF-α, advanced
      glycation end products (AGEs ), IL-6, and HbA1c of diabetes type 2 patients.

      In this randomized, double-blind clinical trial, placebo-controlled study, 84 women and men
      with type 2 diabetes are enrolled from the Iranian Center of diabetes. At the start of study,
      all participants will sign informed consent and complete a general information form. 24-hour
      food record for 3 days will be taken from the patients at the beginning and the end of the
      study. Selected samples by using stratified randomization method based on sex, gender and
      body mass index (BMI) are classified into 2 groups: 1) receiving vitamin D supplement 2)
      receiving vitamin D placebo bo.

      The vitamin D supplement group will receive 4000 IU (100 microgram) daily for 3 months. The
      vitamin D placebo group will also receive placebo containing starch both similar in terms of
      color, shape and size. participants are advised to maintain their diet, level of physical
      activity and medication dose during the study. Blood samples will be collected after
      anthropometric parameter measuring then target biochemical parameters, gene expression and
      serum levels and physical activity will be measured before and after the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: serum HbA1c
time frame: Change frome baseline at 3 months
measure: serum fasting insulin
time frame: Change frome baseline at 3 months
measure: serum Fasting blood suger,
time frame: Change frome baseline at 3 months
measure: serum AGES
time frame: Change frome baseline at 3 months
measure: serum IL6
time frame: Change frome baseline at 3 months
measure: serum TNF-alpha
time frame: Change frome baseline at 3 months
measure: serum PAI-1
time frame: Change frome baseline at 3 months
measure: RAGE gene expression
time frame: Change frome baseline at 3 months
measure: YKL40 gene expression
time frame: Change frome baseline at 3 months
measure: glyoxalase enzyme gene expression
time frame: Change frome baseline at 3 months
measure: serum IL-17
time frame: Change frome baseline at 3 months
measure: Serum IL-4
time frame: Change frome baseline at 3 months
measure: serum Transforming growth factor beta
time frame: Change frome baseline at 3 months
measure: serum YKL40
time frame: Change frome baseline at 3 months
arm group label: vitamin D supplementation
arm group type: Active Comparator
description: patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.
arm group label: vitamin D placebo
arm group type: Placebo Comparator
description: patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months
intervention type: Dietary Supplement
intervention name: vitamin D
description: vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months
arm group label: vitamin D supplementation
intervention type: Dietary Supplement
intervention name: vitamin D placebo
description: vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months
arm group label: vitamin D placebo
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins