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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314561
• Other study ID #: KoreaUAnanmH
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2006
• Last updated: June 30, 2011
• Start date: May 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2008
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Pioglitazone, Rosiglitazone

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
Secondary	The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-a, hsCRP.