<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/NCT02185963</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH_ENDO05</org_study_id>
    <nct_id>NCT02185963</nct_id>
  </id_info>
  <brief_title>Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes</brief_title>
  <official_title>Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patients who have achieved LDL-C levels below the currently recommended targets may still&#xD;
      experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD),&#xD;
      raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased&#xD;
      HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether&#xD;
      functional HDL is more important than total circulating levels of HDL-C in reducing CHD.&#xD;
&#xD;
      Actually, the increased concentration of HDL alone might be ineffective indicating that&#xD;
      qualitative changes in HDL levels in response to drug interventions are required to result in&#xD;
      clinical benefit.&#xD;
&#xD;
      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on&#xD;
      functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study design Study subject Number of Subjects (N = 30)&#xD;
&#xD;
        2. Study outcome&#xD;
&#xD;
           Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol&#xD;
&#xD;
        3. Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced&#xD;
           monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte&#xD;
           chemotactic protein-1 (MCP-1)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional HDL-C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cholesterol efflux from macrophages&#xD;
LDL-induced monocyte chemotactic activity (MCA) Assay&#xD;
Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-HDL-cholesterol = total cholesterol - HDL-C</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with LDL-C &lt; 70 mg/dl and HDL &gt; 40 mg/dl in men; &gt; 50 in women</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Rosuvastatin 20mg once a daily for 12 weeks</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Crestor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 2 diabetes&#xD;
&#xD;
          2. HbA1c ≥ 7.5%&#xD;
&#xD;
          3. Age ≥ 30&#xD;
&#xD;
          4. low HDL-C (&lt;40 mg/dl in men or &lt;50 mg/dl in women) and having 1 or more risk factors:&#xD;
             1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG&#xD;
             level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP)&#xD;
             ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family&#xD;
             history of CHD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to rosuvastatin&#xD;
&#xD;
          2. Pregnant or breast feeding women&#xD;
&#xD;
          3. Reproductive-age women who refuse contraception&#xD;
&#xD;
          4. Type 1 diabetes, gestational diabetes, or diabetes with secondary cause&#xD;
&#xD;
          5. Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT &gt;&#xD;
             3-fold the upper limit of normal)&#xD;
&#xD;
          6. Renal failure (Cr &gt; 2.0)&#xD;
&#xD;
          7. Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer&#xD;
             with appropriate treatment)&#xD;
&#xD;
          8. Not appropriate for lipid lowering treatment&#xD;
&#xD;
          9. Medications which affect glycemic control&#xD;
&#xD;
         10. Diseases which affect efficacy and safety of statin&#xD;
&#xD;
         11. Other clinical trial within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soo Lim, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>May 2, 2016</last_update_submitted>
  <last_update_submitted_qc>May 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Soo Lim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>HDL function</keyword>
  <keyword>Cholesterol efflux</keyword>
  <keyword>MCA assay</keyword>
  <keyword>MCP-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</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/NCT02185963
org study id: SNUBH_ENDO05
nct id: NCT02185963
lead sponsor: 
has dmc: Yes
The patients who have achieved LDL-C levels below the currently recommended targets may still
      experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD),
      raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased
      HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether
      functional HDL is more important than total circulating levels of HDL-C in reducing CHD.

      Actually, the increased concentration of HDL alone might be ineffective indicating that
      qualitative changes in HDL levels in response to drug interventions are required to result in
      clinical benefit.

      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on
      functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.
1. Study design Study subject Number of Subjects (N = 30)

        2. Study outcome

           Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol

        3. Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced
           monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte
           chemotactic protein-1 (MCP-1)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional HDL-C
time frame: 12 weeks
description: Cholesterol efflux from macrophages
LDL-induced monocyte chemotactic activity (MCA) Assay
Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)
measure: Non-HDL-cholesterol = total cholesterol - HDL-C
time frame: 12 weeks
measure: Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women
time frame: 12 weeks
arm group label: Rosuvastatin
arm group type: Experimental
description: Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors
intervention type: Drug
intervention name: Rosuvastatin
description: Rosuvastatin 20mg once a daily for 12 weeks
arm group label: Rosuvastatin
other name: Crestor
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Soo Lim, PHD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Soo Lim
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Rosuvastatin Calcium