Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2006

Last Updated Date

May 6, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

u-AQP-2
FeNa+

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00281710 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Official Title ^ICMJE

Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Brief Summary

We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Single Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Methylprednisolone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

(1) Genders; both mal and female
(2) Age; 18- 65 years old
(3) BMI; below 30
(4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

(1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
(2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
(3) Albuminuria or glucosuria
(4) Cancer
(5) Arterial hypertension
(6) Alcohol abuse
(7) Use of tobacco
(8) Medical treatment, except oral contraceptives
(9) Pregnancy or breast feeding
(10) Medicine abuse
(11) Donation of blood less than 1 month before the study.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00281710

Responsible Party

Study ID Numbers ^ICMJE

MED.RES.HOS.2005.02.TGK

Study Sponsor ^ICMJE

Holstebro Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Erling B Pedersen, Professor	Holstebro Hospital, 7500 Holstebro, Denmark
Principal Investigator:	Thomas G Knudsen, MD	Holstebro Sygehus

Information Provided By

Holstebro Hospital

Verification Date

May 2008

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