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

Phase 4

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT00314561
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-12
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-14
• Study Start: 2006-05
• Study Completion: 2006-12
• Status Verified: 2008-09
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)

Secondary Outcome Measures

Name	Time	Method
The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of