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Completed

NCT Number: NCT00678522

The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type II diabetes, not in treatment with insulin.

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Key information

Conditions

Healthy Subjects Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medical Research, Holstebro Hospital, Holstebro, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 40-70 yrs
  • estimated GFR between 30 and 90 ml/min
  • BMI<35
  • Fertile women had to use oral contraceptives or IUD
  • HbA1c< 10%
  • Urine-albumin<1,5 g/l

Exclusion criteria

  • Treatment with insulin
  • Cerobrovascular insult or other disease of the brain
  • Insufficiency of the heart or lungs
  • Liverdisease with ALAT > 200 U/L
  • hemoglobin < 7,0 mmol/l
  • Cancer
  • Alcohol abuse
  • Medical treatment with psycopharmaca or/and analgetics
  • Pregnancy and breast feeding, 10 blood donation one month before the study.

Treatment and study plan

atorvastatin

Drug

80 mg atorvastatin daily on two following days

Primary outcomes

  1. GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance.

    Time frame: 6 months

Secondary outcomes

  1. AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Collaborators

  • Medical Research

Registry information

Official study title

The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 15, 2008
Registry last updated
May 15, 2008

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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