Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome

Not Applicable

Completed

Conditions: Metabolic syndrome
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN04503926

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Carotid-intima media thickness<br>2. Left ventricular mass<br>3. Insulin resistance<br>4. Inflammatory markers <br>5. Coagulation factors<br><br>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.