Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/02/2006
Date assigned
04/04/2006
Last edited
29/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brona Loughrey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT000255

Study information

Scientific title

Acronym

Study hypothesis

That treatment with atorvastatin will lead to improvement in monocyte phenotype in individuals at risk of cardiovasular disease

Ethics approval

HPSS REC3, one of the Research Ethics Committees of Northern Ireland, on the 2nd August 2006 (ref: 06/NIR03/79).

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Metabolic syndrome

Intervention

Treatment with atorvastatin 10 mg per day versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Atorvastatin

Primary outcome measures

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 trial start date

01/08/2006

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/08/2006

Recruitment end date

31/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Biochemistry
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

Royal Group of Hospitals Trust (UK)

Sponsor details

Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Northern Ireland Research and Development Office (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes