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

Phase 4

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00678522
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Last Update Submitted: 2008-05-14
• Study First Posted: 2008-05-15
• Last Update Posted: 2008-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.	6 months

Secondary Outcome Measures

Name	Time	Method
AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.	6 months

Trial Locations

Locations (2)

Medical Reseach, Holstebro Hospital; 🇩🇰 Holstebro, Denmark

Department of Medical Research, Holstebro Hospital; 🇩🇰 Holstebro, Denmark