Effect of statin therapy on monocyte function in the metabolic syndrome

ISRCTN	ISRCTN71301517
DOI	https://doi.org/10.1186/ISRCTN71301517
Protocol serial number	RGHT000255
Sponsor	Royal Group of Hospitals Trust (UK)
Funder	The Northern Ireland Research and Development Office (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Brona Loughrey
Scientific

Department of Clinical Biochemistry
Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	That treatment with atorvastatin will lead to improvement in monocyte phenotype in individuals at risk of cardiovasular disease
Ethics approval(s)	HPSS REC3, one of the Research Ethics Committees of Northern Ireland, on the 2nd August 2006 (ref: 06/NIR03/79).
Health condition(s) or problem(s) studied	Metabolic syndrome
Intervention	Treatment with atorvastatin 10 mg per day versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure(s)	Measurement of monocyte response to chemotaxins in vitro (the chemotactic index)
Key secondary outcome measure(s)	Measurement of expression of other molecules (e.g. cell adhesion molecules) involved in atherosclerosis in serum, monocytes and human endothelial cells exposed to patient serum
Completion date	31/07/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Age 35 - 63 years 2. Metabolic syndrome as defined by the International Diabetes Federation, central obesity plus two of the following: 2.1. Hypertension 2.2. Glucose intolerance 2.3. Low levels of high-density lipoprotein cholesterol (HDL-C) 2.4. Hypertriglyceridemia Control subjects must have none of these features.
Key exclusion criteria	1. Pre-existing indication for lipid-lowering therapy, or history of intolerance of these agents 2. Use of insulin or hormone replacement therapy 3. History of liver or muscle disease 4. Impaired renal function 5. Potential for pregnancy (females) 6. Total cholesterol greater than 6.5 mmol/l or less than 4 mmol/l
Date of first enrolment	01/08/2006
Date of final enrolment	31/07/2009

Department of Clinical Biochemistry

Belfast
BT12 6BA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan