Metabolic Syndrome
Conditions
Keywords
Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis
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.
Interventions
DRUGPioglitazone, Rosiglitazone
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV) | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP. | — |
Countries
South Korea
Outcome results
None listed