Rosuvastatin in Visceral Adiposity. A 26-week, single center, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the effect of rosuvastatin on visceral adipose tissue in male subjects with abdominal obesity

INTERVENTION: Trade Name: Crestor® Product Name: Rosuvastatincaclium Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Visceral adiposity PRIMARY OUTCOME: Main Objective: To investigate the effect of a 26‐week rosuvastatin‐treatment compared with placebo on visceral adipose tissue area in male subjects with abdominal adiposity (CT). Primary end point(s): Change from baseline in the intra‐abdominal adipose tissue area measured by computed tomography. Secondary Objective: To determine the effect of statin‐treatment on fatty infiltration in the liver (CT), muscle attenuation values (CT), glycemia, lipid levels and gene expression in subcutaneous adipose tissue. INCLUSION CRITERIA: Male patients between 40 and 65 years of age with abdominal obesity defined by a waist circumference greater than or equal to 102 cm and dyslipidemia (LDL‐cholesterol = 3.0 mmol/l or HDL‐cholesterol = 1.0 mmol/l or Triglycerids = 1.7 mmol/l). Informed concent. 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