Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00281710
First received: January 23, 2006
Last updated: May 6, 2008
Last verified: May 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

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

Locations
Denmark
Department of Medicine, Holstebro Hospital
Holstebro, Denmark
Sponsors and Collaborators
Regional Hospital Holstebro
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

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

Keywords provided by Regional Hospital Holstebro:
AQP-2
Methylprednisolone
Urinary concentrating ability

Additional relevant MeSH terms:
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014