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

This study has been completed.
Information provided by:
Korea University Anam Hospital Identifier:
First received: April 12, 2006
Last updated: June 30, 2011
Last verified: September 2008
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00314561

Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Principal Investigator: Dong Sup Choi, MD, PhD Korea University Anam Hospital
  More Information Identifier: NCT00314561     History of Changes
Other Study ID Numbers: KoreaUAnanmH
Study First Received: April 12, 2006
Last Updated: June 30, 2011

Keywords provided by Korea University Anam Hospital:

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017