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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01208701
First received: September 19, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Nephropathy
Cardiovascular Diseases
Diabetes Mellitus
 Drug: Atorvastatin
Drug: Unikalk
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Fractional excretion of sodium [ Time Frame: 5 days treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin Drug: Atorvastatin
Zarator, 80 mg pr day for 5 days
Other Name: Zarator
Placebo Comparator: Placebo Drug: Unikalk
1 tablet Unikalk pr day for 5 days
Other Name: Unikalk

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208701

Locations
Denmark
Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Frank H Christensen, MD Department of Medical Research
  More Information

No publications provided

Responsible Party: Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01208701     History of Changes
Other Study ID Numbers: EBP-FHC-2010-3
Study First Received: September 19, 2010
Last Updated: January 27, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regional Hospital Holstebro:
Atorvastatin
L-NMMA
NO
Nephrology
Diabetes Mellitus

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013