NCT01214746

The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Regional Hospital Holstebro · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.

Detailed description

Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet. On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion. Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron. Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor. The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma

Conditions

• Cardiovascular Diseases
• Nephropathy

Interventions

Type	Name	Description
DRUG	Placebo	1 tablet Unikalk 1 time pr day for 5 days
DRUG	Atorvastatin	Zarator, 80 mg pr day for 5 days

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-10-05
• Last updated: 2011-08-16

Locations

1 site across 1 country: Denmark