<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/NCT01700075</url>
  </required_header>
  <id_info>
    <org_study_id>0109RK000079</org_study_id>
    <nct_id>NCT01700075</nct_id>
  </id_info>
  <brief_title>Physical and Chemical Study of Atherosclerosis Mechanisms</brief_title>
  <acronym>PCSAM</acronym>
  <official_title>Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nazarbayev University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Kazakhstan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nazarbayev University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical&#xD;
      properties of lipid tissues at various localization with subsequent development of concept of&#xD;
      treatment and prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The chemical and physical properties of different lipids of body. The clinical part of the&#xD;
      work is a prospective randomized comparative controlled clinical trial of patients with&#xD;
      atherosclerotic diseases.&#xD;
&#xD;
      Developed the concept of &quot;limited biological resources&quot; of the body based on the increase in&#xD;
      the expenditure of energy reserves of the body, allowing a critical look at overweight.&#xD;
&#xD;
      The role of overweight in the development of atheromatous fat was revealed. The positive&#xD;
      results from the weight loss in patients with atherosclerotic disease were drawn. Developed&#xD;
      the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of&#xD;
      lipids in hard atherosclerotic fat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>full recovery from atherosclerotic diseases</measure>
    <time_frame>for 12 months</time_frame>
    <description>Regression of atherosclerosis plaque in vessel: imaging methods (GE Vivid 7 Ultrasound; GE Healthcare Worldwide USA, Michigan), and computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).&#xD;
Improvement of clinical condition: by measurement of clinical presence status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>normalised laboratory and instrumental data</measure>
    <time_frame>for 12 month</time_frame>
    <description>Weight loss: Tanita-SC330S Body Composition Analyzer (Tanita Corp., Tokyo, Japan) including weight (kg), body mass index (BMI, kg/m2), body composition parameters, including as fat mass (in % of total body weight and total kg), visceral fat rating (units), fat free mass (kg), total body water (in % and kg), muscle mass (in % and kg), bone mass (in % and kg), metabolic age (years), basal metabolic rate (kcal per day), and bioimpedance (Ohms).&#xD;
Rate of blood circulation: Dopler Ultrasound (GE Healthcare Worldwide USA, Michigan).&#xD;
Bone density: bone densitometry (Lunar Achilles Express Ultrasound; GE Healthcare USA, Madison).&#xD;
Imaging of internal organs and blood vessel diameter: computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).&#xD;
General clinical study of blood and urine, liver and kidneys function tests, glucose and lipids levels.&#xD;
Clinical condition in dynamics: clinical presence status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Artery Diseases</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Atherosclerosis of Femoral Artery</condition>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lipidlowering: &quot;Atorvastatin&quot; (Liprimar) - 40mg per day. Antihypertensive: &quot;Diroton&quot; (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and &quot;Ditiazem&quot; (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.&#xD;
Antihyperglycemic drugs: biguanides &quot;Metformin&quot; - 0.5 g two or tree times per day, or &quot;Exenatide&quot; - 5-10 µg per day.&#xD;
Anti-inflammatory: &quot;TromboACC&quot; (acetylsalicylate acid) up to 2 g per day and/or &quot;Clopidogrel&quot; (thienopyridine class antiplatelet agent) - 75mg per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight loss treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional treatment</intervention_name>
    <description>Lipidlowering: &quot;Atorvastatin&quot; (Liprimar) - 40mg per day. Antihypertensive: &quot;Diroton&quot; (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and &quot;Ditiazem&quot; (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.&#xD;
Antihyperglycemic drugs: biguanides &quot;Metformin&quot; - 0.5 g two or tree times per day, or &quot;Exenatide&quot; - 5-10 µg per day.&#xD;
Anti-inflammatory: &quot;TromboACC&quot; (acetylsalicylate acid) up to 2 g per day and/or &quot;Clopidogrel&quot; (thienopyridine class antiplatelet agent) - 75mg per day.</description>
    <arm_group_label>Conventional treatment</arm_group_label>
    <other_name>Pathogenetic and symptomatic treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Weight loss treatment</intervention_name>
    <description>Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.</description>
    <arm_group_label>Weight loss treatment</arm_group_label>
    <other_name>vegetable and salt diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent form&#xD;
&#xD;
          -  dyslipidemia (HDL &lt;1.0 mmol / l, triglycerides (TG) in plasma ≥ 1,7 mmol / l or&#xD;
             cholesterol ≥ 5,6 mmol /l)&#xD;
&#xD;
          -  waist circumference ≥ 94.0 cm in men or ≥ 80,0 cm in women,&#xD;
&#xD;
          -  BP ≥140/95 mm Hg or a patient is taking antihypertensive medications,&#xD;
&#xD;
          -  fasting glucose ≥ 6,1 mmol / l or the patient is taking hypoglycemic agents,&#xD;
&#xD;
          -  the possibility of treatment for 6 months and follow-up for 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of consent form&#xD;
&#xD;
          -  Non-compliance of patient to necessary recommendations.&#xD;
&#xD;
          -  The presence of mental illness.&#xD;
&#xD;
          -  Complete immobilization of a patient (paresis, and paralysis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuat P Oshakbayev, MD, PhD, DsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientisic research institute of cardiology and internal diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scientific Research Institute of Cardiology and Internal Diseases</name>
      <address>
        <city>Almaty</city>
        <zip>050000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atherosclerosis, development of concept, weight loss therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Infarction</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/NCT01700075
org study id: 0109RK000079
nct id: NCT01700075
lead sponsor: 
collaborator: 
has dmc: Yes
Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical
      properties of lipid tissues at various localization with subsequent development of concept of
      treatment and prevention.
The chemical and physical properties of different lipids of body. The clinical part of the
      work is a prospective randomized comparative controlled clinical trial of patients with
      atherosclerotic diseases.

      Developed the concept of "limited biological resources" of the body based on the increase in
      the expenditure of energy reserves of the body, allowing a critical look at overweight.

      The role of overweight in the development of atheromatous fat was revealed. The positive
      results from the weight loss in patients with atherosclerotic disease were drawn. Developed
      the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of
      lipids in hard atherosclerotic fat.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: full recovery from atherosclerotic diseases
time frame: for 12 months
description: Regression of atherosclerosis plaque in vessel: imaging methods (GE Vivid 7 Ultrasound; GE Healthcare Worldwide USA, Michigan), and computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).
Improvement of clinical condition: by measurement of clinical presence status.
measure: normalised laboratory and instrumental data
time frame: for 12 month
description: Weight loss: Tanita-SC330S Body Composition Analyzer (Tanita Corp., Tokyo, Japan) including weight (kg), body mass index (BMI, kg/m2), body composition parameters, including as fat mass (in % of total body weight and total kg), visceral fat rating (units), fat free mass (kg), total body water (in % and kg), muscle mass (in % and kg), bone mass (in % and kg), metabolic age (years), basal metabolic rate (kcal per day), and bioimpedance (Ohms).
Rate of blood circulation: Dopler Ultrasound (GE Healthcare Worldwide USA, Michigan).
Bone density: bone densitometry (Lunar Achilles Express Ultrasound; GE Healthcare USA, Madison).
Imaging of internal organs and blood vessel diameter: computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).
General clinical study of blood and urine, liver and kidneys function tests, glucose and lipids levels.
Clinical condition in dynamics: clinical presence status.
arm group label: Conventional treatment
arm group type: Active Comparator
description: Lipidlowering: "Atorvastatin" (Liprimar) - 40mg per day. Antihypertensive: "Diroton" (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and "Ditiazem" (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.
Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day.
Anti-inflammatory: "TromboACC" (acetylsalicylate acid) up to 2 g per day and/or "Clopidogrel" (thienopyridine class antiplatelet agent) - 75mg per day.
arm group label: Weight loss treatment
arm group type: Experimental
description: Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.
intervention type: Drug
intervention name: Conventional treatment
description: Lipidlowering: "Atorvastatin" (Liprimar) - 40mg per day. Antihypertensive: "Diroton" (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and "Ditiazem" (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.
Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day.
Anti-inflammatory: "TromboACC" (acetylsalicylate acid) up to 2 g per day and/or "Clopidogrel" (thienopyridine class antiplatelet agent) - 75mg per day.
arm group label: Conventional treatment
other name: Pathogenetic and symptomatic treatment
intervention type: Dietary Supplement
intervention name: Weight loss treatment
description: Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.
arm group label: Weight loss treatment
other name: vegetable and salt diet
criteria: 
gender: All
minimum age: 26 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kuat P Oshakbayev, MD, PhD, DsC
role: Principal Investigator
affiliation: Scientisic research institute of cardiology and internal diseases
facility: 
country: Kazakhstan
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Atherosclerosis
mesh term: Diabetes Mellitus, Type 2
mesh term: Infarction