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

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: NCT00678522
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : May 15, 2008
Medical Research
Information provided by:
Regional Hospital Holstebro

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Atorvastatin
    80 mg atorvastatin daily on two following days

Primary Outcome Measures :
  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 Outcome Measures :
  1. AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR. [ Time Frame: 6 months ]

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT00678522

Medical Reseach, Holstebro Hospital
Holstebro, Denmark, 5500
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Medical Research
Principal Investigator: Erling B. Pedersen, Professor Dept. of medical reaserch, Holstebro Hospital, Denmark

Responsible Party: Lone Paulsen, Medical Research Identifier: NCT00678522     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.04.LP
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by Regional Hospital Holstebro:
Renal function
Diabetes type II
sodium excretion

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors