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

This study has been completed.
Sponsor:
Collaborator:
Medical Research
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00678522
First received: May 13, 2008
Last updated: May 14, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Healthy Subjects
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

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

Estimated Enrollment: 25
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Atorvastatin
    80 mg atorvastatin daily on two following days
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00678522

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

No publications provided

Responsible Party: Lone Paulsen, Medical Research
ClinicalTrials.gov Identifier: NCT00678522     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.04.LP
Study First Received: May 13, 2008
Last Updated: May 14, 2008
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on July 31, 2014