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

May 13, 2008
May 14, 2008
September 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00678522 on ClinicalTrials.gov Archive Site
AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR. [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Subjects
Drug: Atorvastatin
80 mg atorvastatin daily on two following days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00678522
MED.RES.HOS.2006.04.LP
Yes
Lone Paulsen, Medical Research
Regional Hospital Holstebro
Medical Research
Principal Investigator: Erling B. Pedersen, Professor Dept. of medical reaserch, Holstebro Hospital, Denmark
Regional Hospital Holstebro
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP