Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of 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).

Conditions

• Adverse Effect
• Atherosclerosis, Coronary
• Insulin Resistance Syndrome

Interventions

DRUG

Pioglitazone 15 mg Tablet

Pioglar (Ranbaxy India):1 tablet per day in the morning for 6 months

DRUG

Isosorbide Dinitrate 10Mg Tablet

1-2 tablets 2 times a day

DRUG

Acetylsalicylic Acid 75Mg Tablet

1 tablet per a day

DRUG

Bisoprolol Fumarate 2.5 MG Oral Tablet

1 tablet per a day

DRUG

Rosuvastatin Calcium 20 MG Oral Tablet

1 tablet per a day

DRUG

Ramipril 5 MG

1 tablet per a day

Sponsors & Collaborators

• Ukrainian Medical Stomatological Academy

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

68 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2014-06-30

Completion

2015-09-30

Countries

• Ukraine

Study Locations