Effect of statin therapy on monocyte function in the metabolic syndrome.

INTERVENTION: Trade Name: Lipitor Product Name: Lipitor Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Metabolic syndrome, the essential feature of which is central obesity PRIMARY OUTCOME: Main Objective: To determine whether treatment of obese subjects with the metabolic syndrome with atorvastatin results in decreased propensity for monocyte chemotaxis. Primary end point(s): Chemotactic response of extracted monocytes; Serum inflammatory markers e.g interleukin‐8, monocyte chemoattractant protein 1; Monocyte receptor expression ; Induction of adhesion molecule expression by subject serum on cultured endothelial cells Secondary Objective: To determine the effect of atorvastatin on other aspects of the inflammatory response: serum cytokines, monocyte receptor expression and ability of serum to induce adhesion molecule expression on an endothelial cell line in vitro. INCLUSION CRITERIA: Metabolic syndrome, as defined by the International Diabetes Federation (2005). This is present if a person has central obesity (waist circumference > 94cm for Europid men; > 80 cm for Europid women) plus at least two of the following features: ? Blood pressure = 130/85 mmHg, or on treatment for hypertension. ? Fasting plasma glucose = 5.6 mmol/l, or previously diagnosed Type II diabetes. ? Fasting triglycerides = 1.7 mmol/l. ? High‐density cholesterol < 1.03 mmol/l (men) or < 1.29 mmol/l (women). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range