The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy
NCT ID: NCT01208701
Last Updated: 2015-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Atorvastatin
Atorvastatin
Zarator, 80 mg pr day for 5 days
Placebo
Unikalk
1 tablet Unikalk pr day for 5 days
Interventions
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Atorvastatin
Zarator, 80 mg pr day for 5 days
Unikalk
1 tablet Unikalk pr day for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* minimum 40 years
* Chronic Kidney disease
* Estimated GFR (eGFR) between 30 and 90 ml/min
* Diabetes Mellitus type II
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Erling Bjerregaard Pedersen
OTHER
Responsible Party
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Erling Bjerregaard Pedersen
professor chief physician
Principal Investigators
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Frank H Christensen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Research
Locations
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Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, , Denmark
Countries
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References
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Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
Mose FH, Larsen T, Jensen JM, Hansen AB, Bech JN, Pedersen EB. Effect of atorvastatin on renal NO availability and tubular function in patients with stage II-III chronic kidney disease and type 2 diabetes. Scand J Clin Lab Invest. 2014 Jan;74(1):8-19. doi: 10.3109/00365513.2013.855942. Epub 2013 Nov 21.
Other Identifiers
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EBP-FHC-2010-3
Identifier Type: -
Identifier Source: org_study_id
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