Objectives:To investigate whether statins (3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors) improve endothelial dysfunction in healthy volunteers (men). Endothelial dysfunction is an early marker of atherosclerosis. Design: Phase IV, Single-centered, Open label, 20 male volunteers, Proof of concept study
Conditions
Interventions
Trade Name: Simvastatin 40 mg
Product Name: Simvastatin 40 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SIMVASTATIN
CAS Number: 79902639
Current Sponsor code: CD07/8396
Concentratio
Sponsors
University of Leeds
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: We will recruit sedentary * Males * Age 18 to 40 years * Body mass index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Female gender * Age 40 years * Hypertension * Diabetes mellitus * Current smokers * Liver disease (including abnormal liver function tests and / or a history of liver disease) * Alcohol abuse * Cancer * Ischaemic heart disease * Unwilling to refrain from drinking grapefruit juice * Currently taking statins * Contraindications to statins (according to the British National Formulary and assessed by taking a history and blood tests at the preliminary visit). * Ingestion of large quantities of grapefruit juice * Participating in another trial or have done so in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does simvastatin improve endothelial dysfunction in men?;Secondary Objective: Does simvastatin improve nitric oxide (NO) bioavailability in conduit and resistance vessels of healthy young men? Does simvastatin increase endothelial progenitor cell number and function in healthy young men? ;Primary end point(s): Measures of endothelial dysfunction in men Secondary endpoints:Nitric oxide (NO) bioavailability in conduit and resistance vessels and endothelial progenitor cell number and function | — |
Countries
United Kingdom
Outcome results
None listed