<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/NCT03784703</url>
  </required_header>
  <id_info>
    <org_study_id>Statin Therapy</org_study_id>
    <nct_id>NCT03784703</nct_id>
  </id_info>
  <brief_title>Type 2 Diabetic Patients Maintained on Statin Therapy</brief_title>
  <official_title>Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damanhour University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Damanhour University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular&#xD;
      disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD&#xD;
      risk is recommended. However, the risk is still present. Therefore, we investigated the&#xD;
      impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin&#xD;
      biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in&#xD;
      diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion&#xD;
      criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either&#xD;
      40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group,&#xD;
      n= 80) for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a prospective, double blind trial, conducted between January 2018 and January 2020.&#xD;
      Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of&#xD;
      10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and&#xD;
      LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the&#xD;
      study. Of 150 patients were randomly assigned to receive either 40 mg per day atorvastatin&#xD;
      tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®,&#xD;
      Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III&#xD;
      (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA)&#xD;
      according to their treatment regimen. Clinical and biochemical assessment was done at&#xD;
      baseline and after 6 months. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and&#xD;
      Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical&#xD;
      parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight&#xD;
      (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting&#xD;
      position for 15 min. The mean value of two consecutive measurements with 5 min intervals was&#xD;
      used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides&#xD;
      (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were&#xD;
      determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated&#xD;
      according to Friedewald formula. Atherogenic Index (AI) is calculated through the following:&#xD;
      Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a&#xD;
      good biomarker for deciding on the intensity and the need for therapeutic intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>
    <intervention_model_description>160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>prospective, double blind trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>hs-CRP (pg/mL)</measure>
    <time_frame>6 months</time_frame>
    <description>biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sortilin (ng/mL)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum Level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adiponectin (ng/mL)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum Level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>leptin (ng/mL)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum Level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glucose level</measure>
    <time_frame>6 months</time_frame>
    <description>fasting blood glucose (FBG) (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glycated hemoglobin</measure>
    <time_frame>6 months</time_frame>
    <description>glycated hemoglobin (Hb A1c%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>TCH: total cholesterol (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>low density lipoprotein-cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high density lipoprotein-cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>6 months</time_frame>
    <description>Triglycerides (mg/dL).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Dyslipidemia Associated With Type II Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Atrovastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>atorvastatin (40 mg per day) for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuvastatin (10 mg per day) for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 40 Mg Oral Tablet</intervention_name>
    <description>40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months</description>
    <arm_group_label>Atrovastatin</arm_group_label>
    <other_name>Atorvastatin 40mg tablet per day</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 10 Mg Oral Tablet</intervention_name>
    <description>10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Resovastatin 10 mg daily</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type II diabetic patients with hypercholesterolemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver impairment,&#xD;
&#xD;
          -  renal insufficiency,&#xD;
&#xD;
          -  coronary artery disease,&#xD;
&#xD;
          -  metabolic disorders,&#xD;
&#xD;
          -  type I diabetes,&#xD;
&#xD;
          -  autoimmune diseases, cancer, infection,&#xD;
&#xD;
          -  use of anti-inflammatory drugs,&#xD;
&#xD;
          -  recent major surgery,&#xD;
&#xD;
          -  weight-loss or modified anti-hypertensive medications 12 weeks or less prior to&#xD;
             enrolment,&#xD;
&#xD;
          -  ongoing or previous use of lipid-lowering medications (including other statins, fibric&#xD;
             acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids)&#xD;
             and contraindications to the use of statins.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehab Werida, Lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Damanhour University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tanta University Hospital</name>
      <address>
        <city>Tanta</city>
        <state>El-Gharbia</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.</citation>
    <PMID>24354929</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Damanhour University</investigator_affiliation>
    <investigator_full_name>Rehab Werida</investigator_full_name>
    <investigator_title>Clinical Pharmacy Lecturer</investigator_title>
  </responsible_party>
  <keyword>Adiponectin</keyword>
  <keyword>Sortilin</keyword>
  <keyword>Leptin</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Diabetes type II</keyword>
  <keyword>Rosuvastatin</keyword>
  <keyword>Atorvastatin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03784703
org study id: Statin Therapy
nct id: NCT03784703
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular
      disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD
      risk is recommended. However, the risk is still present. Therefore, we investigated the
      impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin
      biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in
      diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion
      criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either
      40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group,
      n= 80) for 6 months.
a prospective, double blind trial, conducted between January 2018 and January 2020.
      Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of
      10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and
      LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the
      study. Of 150 patients were randomly assigned to receive either 40 mg per day atorvastatin
      tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®,
      Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III
      (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA)
      according to their treatment regimen. Clinical and biochemical assessment was done at
      baseline and after 6 months. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and
      Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical
      parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight
      (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting
      position for 15 min. The mean value of two consecutive measurements with 5 min intervals was
      used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides
      (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were
      determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated
      according to Friedewald formula. Atherogenic Index (AI) is calculated through the following:
      Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a
      good biomarker for deciding on the intensity and the need for therapeutic intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: prospective, double blind trial
measure: hs-CRP (pg/mL)
time frame: 6 months
description: biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.
measure: sortilin (ng/mL)
time frame: 6 months
description: Serum Level
measure: adiponectin (ng/mL)
time frame: 6 months
description: Serum Level
measure: leptin (ng/mL)
time frame: 6 months
description: Serum Level
measure: glucose level
time frame: 6 months
description: fasting blood glucose (FBG) (mg/mL)
measure: glycated hemoglobin
time frame: 6 months
description: glycated hemoglobin (Hb A1c%)
measure: total cholesterol
time frame: 6 months
description: TCH: total cholesterol (mg/dL)
measure: low density lipoprotein-cholesterol
time frame: 6 months
description: LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
measure: high density lipoprotein-cholesterol
time frame: 6 months
description: HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
measure: Triglycerides
time frame: 6 months
description: Triglycerides (mg/dL).
arm group label: Atrovastatin
arm group type: Experimental
description: atorvastatin (40 mg per day) for 6 months
arm group label: Rosuvastatin
arm group type: Experimental
description: Rosuvastatin (10 mg per day) for 6 months
intervention type: Drug
intervention name: Atorvastatin 40 Mg Oral Tablet
description: 40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months
arm group label: Atrovastatin
other name: Atorvastatin 40mg tablet per day
intervention type: Drug
intervention name: Rosuvastatin 10 Mg Oral Tablet
description: 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months
arm group label: Rosuvastatin
other name: Resovastatin 10 mg daily
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rehab Werida, Lecturer
role: Study Director
affiliation: Damanhour University
facility: 
country: Egypt
citation: Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.
PMID: 24354929
responsible party type: Principal Investigator
investigator affiliation: Damanhour University
investigator full name: Rehab Werida
investigator title: Clinical Pharmacy Lecturer
mesh term: Dyslipidemias
mesh term: Diabetes Mellitus, Type 2
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
sharing ipd: No