- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282321
High-protein and High-carbohydrate Diets' Effect on Urinary Concentrating Ability
February 19, 2010 updated by: Regional Hospital Holstebro
We wanted to test urinary concentrating ability and AQP-2 expression in kidney during high-protein and high-carbohydrate diet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Holstebro, Denmark
- Department of Medicine, Holstebro Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
u-AQP-2
|
FeNa+
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Erling B Pedersen, Professor, Holstebro Hospital, 7500 Holstebro Denmark
- Principal Investigator: Thomas G Knudsen, MD, Holstebro Hospital, 7500 Holstebro, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 24, 2006
First Submitted That Met QC Criteria
January 24, 2006
First Posted (Estimate)
January 26, 2006
Study Record Updates
Last Update Posted (Estimate)
February 22, 2010
Last Update Submitted That Met QC Criteria
February 19, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- MED.RES.HOS.2006.01.TGK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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