Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease
Condition: Adverse Effect; Atherosclerosis, Coronary; Insulin Resistance Syndrome
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Insulin Resistance; Metabolic Syndrome; Disease Progression
Intervention: Pioglitazone 15 mg Tablet; Isosorbide Dinitrate 10Mg Tablet; Acetylsalicylic Acid 75Mg Tablet; Bisoprolol Fumarate 2.5 MG Oral Tablet; Rosuvastatin Calcium 20 MG Oral Tablet; Ramipril 5 MG
Intervention description: Pioglar (Ranbaxy India):1 tablet per day in the morning for 6 months; 1-2 tablets 2 times a day; 1 tablet per a day; 1 tablet per a day; 1 tablet per a day; 1 tablet per a day
Intervention MeSH terms: Aspirin; Pioglitazone; Hypoglycemic Agents; Ramipril; Bisoprolol; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Vasodilator Agents; Platelet Aggregation Inhibitors; Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 45 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Pioglitazone, Insulin Resistance; Atherosclerosis, Coronary Heart Disease

Summary:

      Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the
      peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ regulates
      carbohydrate and lipid metabolism, immune and inflammatory responses in heart tissues.

      Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course
      of atherosclerosis and coronary heart disease (CHD).

      The study will include 43 patients with coronary artery disease. Patients will be divided
      into the study group - 20 patients, in whom pioglitazone will be included in the combined
      therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23 patients
      receiving standard complex drug therapy over 6 months. Patients will be underwent clinical
      examination, ultrasound of neck vessels, study of carbohydrate and lipid metabolism.

      The end primary points of the study will be the onset of death due to myocardial infarction,
      coronary revascularization procedures (coronary artery bypass grafting (CABG) or percutaneous
      coronary intervention (PCI)), or hospitalization for acute coronary syndrome (ACS) or
      unstable angina (UA).

      Predefined secondary end points included carotic atherosclerotic leisure (carotic
      intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic
      inflammation level (the level of C reactive protein), lipid metabolism (levels of serum total
      cholesterol, triglycerides, high and low density lipoproteins), level of insulin resistance (
      oral glucose tolerance test, blood glucose).
    

Eligibility criteria:

        Inclusion Criteria:

          -  stable exertional angina,

          -  type 2 diabetes mellitus (DM) without receiving injectable antidiabetic drugs

        Exclusion Criteria:

          -  the presence of myocardial infarction history, intervention;

          -  malignant arterial hypertension (AH);

          -  chronic heart failure (HF) of III-IV functional class (FC);

          -  systemic connective tissue diseases;

          -  cancer and oncohematological diseases, severe infectious diseases, chronic
             inflammatory diseases;

          -  history of acute cerebrovascular accidents;

          -  disorders of cardiac rhythm by atrial fibrillation type.