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Clinical Trials/NCT00314561
NCT00314561CompletedPhase 4

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

Korea University Anam Hospital2 sites in 2 countries40 target enrollmentStarted: May 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (2)

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