Overview

Implications for Treatment of the Metabolic Syndrome

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
Summary
To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion criteria Body mass index (BMI) 20-35 kg/m^2" and "> 3 criteria for the metabolic
syndrome (NCEP III ATP criteria - see below) , one of which will be hypertriglyceridaemia,
i.e. fasting plasma triglycerides >2.0 mmol/L - a cardinal lipid abnormality of the
syndrome

NCEP III ATP metabolic syndrome criteria are:

Waist greater than or equal to 102 cm BP greater than 130 / 85 mmHg TG greater than or
equal to 1.7mmol/l Glucose greater than or equal to 6.1 mmol/l HDL less than 1.0 mmol/l

Exclusion Criteria:

Aged <18 years Aged >75 years Known diabetes; renal, liver, or uncontrolled thyroid
disease; uncontrolled hypertension; treatment with lipid-modifying drugs; antihypertensive
medication; corticosteroid therapy; or hormone replacement therapy.