Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

This study has been completed.

First Received: January 23, 2006 Last Updated: May 6, 2008 History of Changes

Sponsor:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00281710

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Methylprednisolone	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Crossover Assignment
Official Title:	Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Resource links provided by NLM:

Drug Information available for: Methylprednisolone

U.S. FDA Resources

Further study details as provided by Holstebro Hospital:

Primary Outcome Measures:

u-AQP-2
FeNa+

Estimated Enrollment:	20
Study Start Date:	October 2005
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281710

Locations

Denmark
Department of Medicine, Holstebro Hospital
Holstebro, Denmark

Sponsors and Collaborators

Holstebro Hospital

Investigators

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

More Information

No publications provided

Study ID Numbers:	MED.RES.HOS.2005.02.TGK
Study First Received:	January 23, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00281710 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Holstebro Hospital:

AQP-2
Methylprednisolone
Urinary concentrating ability

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Methylprednisolone acetate
Antiemetics
Prednisolone acetate
Hormones

Glucocorticoids
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on November 27, 2009