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

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

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:

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:

Age: 40-70 yrs
estimated GFR between 30 and 90 ml/min
BMI<35
Fertile women had to use oral contraceptives or IUD
HbA1c< 10%
Urine-albumin<1,5 g/l

Exclusion Criteria:

Treatment with insulin
Cerobrovascular insult or other disease of the brain
Insufficiency of the heart or lungs
Liverdisease with ALAT > 200 U/L
hemoglobin < 7,0 mmol/l
Cancer
Alcohol abuse
Medical treatment with psycopharmaca or/and analgetics
Pregnancy and breast feeding, 10 blood donation one month before the study.

Contacts and Locations

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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