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

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00314561

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Drug: Pioglitazone, Rosiglitazone	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial

Study Start Date :

May 1, 2006

Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV) []

Secondary Outcome Measures

The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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