A Phase 2 interventional study of Atorvastatin and Unikalk in Nephropathy, Cardiovascular Diseases and Diabetes Mellitus, sponsored by Erling Bjerregaard Pedersen. Completed at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-08-21.
Sponsored by Erling Bjerregaard Pedersen · Phase 2, Interventional, and Treatment
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.
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.
3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 2,639 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Erling Bjerregaard Pedersen is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Atorvastatin
Drug: Unikalk
Zarator, 80 mg pr day for 5 days
Also known as: Zarator
1 tablet Unikalk pr day for 5 days
Fractional excretion of sodium
Time frame: 5 days treatment
Systolic blood pressure
Time frame: 5 days
Plasma renin concentration
Time frame: 5 days
Arterial stiffness
Time frame: 5 days
Plasma angiotensin II concentration
Time frame: 5 days
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
Augmentations index
Time frame: 5 days
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Erling Bjerregaard Pedersen