Metabolic syndrome Nutritional, Metabolic, Endocrine Metabolic syndrome
Conditions
Interventions
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 (IW
Sponsors
Central Manchester and Manchester Children's Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed