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

NCT ID: NCT01214746

Last Updated: 2011-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 tablet Unikalk 1 time pr day for 5 days

Atorvastatin

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Zarator, 80 mg pr day for 5 days

Interventions

Placebo

1 tablet Unikalk 1 time pr day for 5 days

Intervention Type: DRUG

Atorvastatin

Zarator, 80 mg pr day for 5 days

Intervention Type: DRUG

Other Intervention Names

Unikalk; Zarator

Eligibility Criteria

Inclusion Criteria

• Men and women, age 18-40 years
• Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria

• Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
• Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
• Neoplastic disease
• Alcohol abuse,
• Drug abuse
• Medical treatment except oral anticontraceptive
• Smoking
• Pregnancy or
• Abnormal blood and urine sample
• Abnormal ECG
• Blood donation within a month before examination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Hospital Holstebro

OTHER

Sponsor Role: lead

Responsible Party

Department of Medical Research, Regionshospitalet Holstebro

Principal Investigators

Frank H Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Medicinsk Forskning

Locations

Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, , Denmark

Countries

Denmark

Other Identifiers

EBP-FHC-2010-1

Identifier Type: -

Identifier Source: org_study_id