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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208701
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : August 21, 2015
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

Brief 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.

Condition or disease Intervention/treatment Phase
Nephropathy Cardiovascular Diseases Diabetes Mellitus Drug: Atorvastatin Drug: Unikalk Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
Study Start Date : May 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fractional excretion of sodium [ Time Frame: 5 days treatment ]

Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 5 days ]
  2. Plasma renin concentration [ Time Frame: 5 days ]
  3. Arterial stiffness [ Time Frame: 5 days ]
  4. Plasma angiotensin II concentration [ Time Frame: 5 days ]
  5. 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 ]
  6. Augmentations index [ Time Frame: 5 days ]

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208701

Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen
Principal Investigator: Frank H Christensen, MD Department of Medical Research

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, professor chief physician, Regional Hospital Holstebro Identifier: NCT01208701     History of Changes
Other Study ID Numbers: EBP-FHC-2010-3
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors