The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy (STAD)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy|
- Fractional excretion of sodium [ Time Frame: 5 days treatment ] [ Designated as safety issue: No ]
- Systolic blood pressure [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Plasma renin concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Arterial stiffness [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Plasma angiotensin II concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Augmentations index [ Time Frame: 5 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Atorvastatin||
Zarator, 80 mg pr day for 5 days
Other Name: Zarator
|Placebo Comparator: Placebo||
1 tablet Unikalk pr day for 5 days
Other Name: Unikalk
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208701
|Medicinsk Forskning, Regionshospitalet Holstebro|
|Holstebro, Denmark, 7500|
|Principal Investigator:||Frank H Christensen, MD||Department of Medical Research|