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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314561
First Posted: April 14, 2006
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korea University Anam Hospital
  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 4

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00314561     History of Changes
Other Study ID Numbers: KoreaUAnanmH
First Submitted: April 12, 2006
First Posted: April 14, 2006
Last Update Posted: July 1, 2011
Last Verified: September 2008

Keywords provided by Korea University Anam Hospital:
Rosiglitazone
Pioglitazone
FMD
PWV
atherosclerosis

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs


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