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

This study has been completed.

First Received on April 12, 2006. Last Updated on June 30, 2011 History of Changes

Sponsor:	Korea University Anam Hospital
Information provided by:	Korea University Anam Hospital
ClinicalTrials.gov Identifier:	NCT00314561

Purpose

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	Intervention	Phase
Metabolic Syndrome	Drug: Pioglitazone, Rosiglitazone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Metabolic Syndrome

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

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.

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314561

Locations

Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Principal Investigator:

Dong Sup Choi, MD, PhD

Korea University Anam Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00314561 History of Changes
Other Study ID Numbers:	KoreaUAnanmH
Study First Received:	April 12, 2006
Last Updated:	June 30, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:

Rosiglitazone
Pioglitazone
FMD
PWV
atherosclerosis

Additional relevant MeSH terms:

Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012