Effect of statin therapy on monocyte function in the metabolic syndrome

ISRCTN ISRCTN71301517
DOI https://doi.org/10.1186/ISRCTN71301517
Secondary identifying numbers RGHT000255
Submission date
13/02/2006
Registration date
04/04/2006
Last edited
29/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
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

Contact information

Dr Brona Loughrey
Scientific

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

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThat 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) studiedMetabolic syndrome
InterventionTreatment with atorvastatin 10 mg per day versus placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measureMeasurement of monocyte response to chemotaxins in vitro (the chemotactic index)
Secondary outcome measuresMeasurement of expression of other molecules (e.g. cell adhesion molecules) involved in atherosclerosis in serum, monocytes and human endothelial cells exposed to patient serum
Overall study start date01/08/2006
Completion date31/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2006
Date of final enrolment31/07/2009

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Department of Clinical Biochemistry
Belfast
BT12 6BA
United Kingdom

Sponsor information

Royal Group of Hospitals Trust (UK)
Hospital/treatment centre

Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

ROR logo "ROR" https://ror.org/03rq50d77

Funders

Funder type

Government

The Northern Ireland Research and Development Office (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan