Effect of statin therapy on monocyte function in the metabolic syndrome
ISRCTN | ISRCTN71301517 |
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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
Scientific
Department of Clinical Biochemistry
Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom
Study information
Study design | Randomised double-blind placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Atorvastatin |
Primary outcome measure | Measurement of monocyte response to chemotaxins in vitro (the chemotactic index) |
Secondary outcome measures | 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 |
Overall study start date | 01/08/2006 |
Completion date | 31/07/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Department of Clinical Biochemistry
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Royal Group of Hospitals Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |