Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ukrainian Medical Stomatological Academy
• Treatments: Aspirin; Bisoprolol; Calcium; Insulin; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Pioglitazone; Ramipril; Rosuvastatin Calcium

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.