The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
Information source: Korea University Anam Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: Pioglitazone, Rosiglitazone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Dong Sup Choi, MD, PhD, Principal Investigator, Affiliation: Korea University Anam Hospital
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
Secondary outcome: The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of
Additional Information
Starting date: May 2006
Ending date: December 2006
Last updated: June 26, 2007
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