Metabolic syndrome, the essential feature of which is central obesity
Conditions
Interventions
Trade Name: Lipitor
Product Name: Lipitor
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Capsule*
Route of admin
Sponsors
Royal Group of Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age 65 Childbearing potential in females Use of lipid-lowering therapy, insulin or hormone replacement therapy History of intolerance of lipid-lowering agents History of muscle disease Plasma total cholesterol >6.5 mmol/l or 140 U/l 10-yr cardiovascular risk >20%, assessed clinically with the help of the Joint British Societies Coronary Risk Prediction Charts Group 1: 60 subjects, 35-65 years, with the metabolic syndrome as previously defined. Group 2: 40 subjects, 35-65 years, with no features of the metabolic syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether treatment of obese subjects with the metabolic syndrome with atorvastatin results in decreased propensity for monocyte chemotaxis.;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. ; 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 | — |
Countries
United Kingdom
Outcome results
None listed