The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy

Cardiovascular Diseases Clinical Trial

— STAD  

Official title:

The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208701
• Other study ID #: EBP-FHC-2010-3
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2010
• Last updated: August 19, 2015
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2015
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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 patients with type 2 diabetes with nephropathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Men and women

• minimum 40 years

• Chronic Kidney disease

• Estimated GFR (eGFR) between 30 and 90 ml/min

• Diabetes Mellitus type II

Exclusion Criteria:

• Nephrotic Syndrome

• Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease

• Neoplastic disease

• Alcohol abuse,

• Drug abuse

• Pregnancy or nursing

• Blood donation within a month before examination

• Hgb < 6,0

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Kidney Diseases
• Nephropathy

Intervention

Drug:
• Atorvastatin
Zarator, 80 mg pr day for 5 days
• Unikalk
1 tablet Unikalk pr day for 5 days

Locations

Country	Name	City	State
Denmark	Medicinsk Forskning, Regionshospitalet Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional excretion of sodium		5 days treatment	No
Secondary	Systolic blood pressure		5 days	No
Secondary	Plasma renin concentration		5 days	No
Secondary	Arterial stiffness		5 days	No
Secondary	Plasma angiotensin II concentration		5 days	No
Secondary	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)		5 days	No
Secondary	Augmentations index		5 days	No