Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human suffering and economic costs; however, much of the morbidity associated with long-term microvascular and neuropathic complications can be substantially reduced by interventions that achieve glucose levels close to the nondiabetic range. However, none of the recent intervention studies has demonstrated a benefit of intensive glycemic control on their primary CVD outcomes. The investigators report the findings of a long-term randomized and comparator-controlled clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators compared the effect of pioglitazone with that of metformin on circulating endothelial cell-derived submicroscopic membranous vesicles, termed microparticles: because of their putative role in inflammatory processes and their ability to directly affect endothelial functions, they are gaining increasing popularity as a surrogate marker of cardiovascular outlook. Metformin was chosen as a comparator because the American Diabetes Association recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of pioglitazone is distinct from that of metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
15-45 mg/die
500-2000 mg/die
Department of Geriatrics and Metabolic Diseases
Naples, Italy
Circulating Endothelial microparticles
Time frame: six months
Glucose profile, lipid profile, hemoglobin A1c, carotid intima-media thickness
Time frame: six months
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