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

NCT ID: NCT00678522

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Atorvastatin Renal function Hemodynamics Diabetes type II sodium excretion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin

80 mg atorvastatin daily on two following days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Research

AMBIG

Sponsor Role collaborator

Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Medical Research

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erling B. Pedersen, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of medical reaserch, Holstebro Hospital, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Reseach, Holstebro Hospital

Holstebro, , Denmark

Site Status

Department of Medical Research, Holstebro Hospital

Holstebro, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MED.RES.HOS.2006.04.LP

Identifier Type: -

Identifier Source: org_study_id