Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/10/2007
Date assigned
07/02/2008
Last edited
18/07/2014
Prospective/Retrospective
Retrospectively 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 Rajdeep Khattar

ORCID ID

Contact details

Consultant Cardiologist
Manchester Heart Centre
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 6576
rajdeep.khattar@cmmc.nhs.uk

Additional identifiers

EudraCT number

2006-006986-18

ClinicalTrials.gov number

Protocol/serial number

EudraCT Number: 2006-006986-18

Study information

Scientific title

Acronym

Study hypothesis

The study is conducted on patients with metabolic syndrome. The National Cholesterol Education Program Adult Treatment Panel definition of metabolic syndrome will be applied and includes the presence of three or more of the following components:
1. Waist girth greater than 102 cm in men or greater than 94 cm in women
2. Serum triglycerides greater than 1.7 mmol/l
3. Serum High Density Lipoprotein (HDL)-cholesterol less than 1.04 mmol/l
4. Fasting plasma glucose greater than 6.1 mmol/l
5. Blood pressure greater than 130/85 mmol/l

Null hypothesis:
Enothelial function in patients with metabolic syndrome does not differ significantly from endothelial function in patients with only two or fewer components of metabolic syndrome or control participants. Also, angiotensin receptor blockade has no role in the reversal of endothelial dysfunction.

Our hypothesis:
Our hypothesis is that angiotensin receptor blockade can reverse endothelial dysfunction in patients with metabolic syndrome.

Ethics approval

Ethics application is being submitted to the National Research Ethics Service (NRES) – approval pending as of 29/10/2007

Study design

Randomised placebo-controlled single-centre prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Metabolic syndrome

Intervention

Those with metabolic syndrome (according to the definition in the hypothesis field) will be randomised to receive either valsartan 80 mg once daily or placebo using Interactive Web Response System (IWRS). A total of 120 subjects consisting of 40 normal controls and 40 patients in each treatment arm will be recruited.

Treatment duration is for 6 months. At the end of 6 months blood tests and scan measurements are repeated and compared with baseline values.

Intervention type

Drug

Phase

Not Applicable

Drug names

Valsartan

Primary outcome measures

The primary objective is to test the hypothesis that angiotensin receptor blockade can reverse endothelial dysfunction. The primary endpoint is the change in endothelial function. Baseline measurements and blood tests are done at study initiation and tests are repeated after 6 months and at this point primary and secondary endpoints are measured.

Secondary outcome measures

The secondary objectives are to assess the changes in other surrogate markers of cardiovascular disease.The secondary endpoints include change in:
1. Carotid-intima media thickness
2. Left ventricular mass
3. Insulin resistance
4. Inflammatory markers
5. Coagulation factors

Baseline measurements and blood tests are done at study initiation and tests are repeated after 6 months and at this point primary and secondary endpoints are measured.

Overall trial start date

01/01/2008

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals with metabolic syndrome without diabetes
2. Male or female at least 18 years and less than 80 years
3. Provision of signed informed consent form
4. Females of child-bearing potential (i.e., females who are not chemically or surgically sterilised or females who are not post-menopause) must have a negative urine or blood pregnancy test at enrolment and be willing to use two methods of reliable contraception, one of which must be a barrier method

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total = 120

Participant exclusion criteria

1. Prior history of overt coronary artery disease, cardiac failure, peripheral vascular disease, cerebrovascular disease or diabetes
2. History of significant renal or hepatic disease
3. Pregnant or lactating women
4. Severe hypertension (blood pressure [BP] greater than 180/110 mmHg)
5. Current antihypertensive treatment
6. Current drug therapy directly acting on the renin-angiotensin-aldosterone system
7. Chronic anaemia (haemoglobin less than 10 g/L)
8. Inadequate carotid ultrasonographic/echocardiographic images
9. Excessive alcohol consumption
10. Significant valvular disease
11. History of primary myocardial disease, e.g. dilated cardiomyopathy, viral myocarditis, hypertrophic cardiomyopathy
12. Previous enrolment or randomisation of treatment in the present study
13. Participation in another investigational drug/interventional study in the last 30 days

Recruitment start date

01/01/2008

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Cardiologist
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester and Manchester Children's Hospitals NHS Trust (UK)

Sponsor details

Research and Development
1st Floor Postgraduate Centre
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 3565
research.secretary@cmmc.nhs.uk

Sponsor type

Government

Website

http://www.cmmc.nhs.uk/

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals UK Limited (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