Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Sponsor
Regional Hospital Holstebro (Other)
Overall Status
Completed
CT.gov ID
NCT00281710
Collaborator
(none)
20
1
16
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single
Official Title:
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Feb 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Outcome Measures

Primary Outcome Measures

  1. u-AQP-2 []

  2. FeNa+ []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00281710
Other Study ID Numbers:
  • MED.RES.HOS.2005.02.TGK
First Posted:
Jan 25, 2006
Last Update Posted:
May 9, 2008
Last Verified:
May 1, 2008

Study Results

No Results Posted as of May 9, 2008