3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors: endothelial and endothelial progenitor cell function in men - Simvastatin and endothelial function in me

• Conditions: 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

• Registration Number: EUCTR2007-006234-34-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

We will recruit sedentary
* Males
* Age 18 to 40 years
* Body mass index <30 kg/m2
* Normotensive
* Non-diabetic
* Non-smokers
* Normal liver function, haematology and cholesterol.

Healthy subjects will be identified by taking a medical history at the preliminary visit by a medically qualified researcher.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Female gender
* Age <18 or >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified