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

May 14, 2008 updated by: Regional Hospital Holstebro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 7500
        • Department of Medical Research, Holstebro Hospital
      • Holstebro, Denmark, 5500
        • Medical Reseach, Holstebro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Collaborators

Medical Research

Investigators

  • Principal Investigator: Erling B. Pedersen, Professor, Dept. of medical reaserch, Holstebro Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

May 13, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (ESTIMATE)

May 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2008

Last Update Submitted That Met QC Criteria

May 14, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED.RES.HOS.2006.04.LP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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