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Completed

NCT Number: NCT01208701

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Zarator, 80 mg pr day for 5 days

Other names: Zarator

Unikalk

Drug

1 tablet Unikalk pr day for 5 days

Primary outcomes

  1. Fractional excretion of sodium

    Time frame: 5 days treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Erling Bjerregaard Pedersen

Other

Registry information

Official study title

The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy

Acronym: STAD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2010
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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