The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

Korea University

Status and phase: Completed; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: Pioglitazone, Rosiglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00314561

KoreaUAnanmH

Details and patient eligibility

About

Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for men and < 50 mg/dl for women.
• Age: 18 years and above

Exclusion criteria

• Hypertensive patients with the use of ACE inhibitor or ARB
• Hyperlipidemic patients with the use of statin or fenofibrate
• Patients with any contraindications to the treatment of thiazolidinediones
• Pregnant or lactating patients
• Chronic alcohol or drug abuse
• Hepatic dysfunction
• Renal dysfunction
• Heart failure (EF < 50%)
• Expected life expectancy of < 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)