- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02604875
The Circadian Rhythm of Copeptin (Co-Rhythm)
August 12, 2016 updated by: University Hospital, Basel, Switzerland
The circadian rhythm of copeptin will be examined in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In 18 healthy volunteers the circadian rhythm of copeptin will be examined by withdrawing blood samples for copeptin levels every 30 minutes for 24 hours.
Study Type
Observational
Enrollment (Actual)
18
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
-
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
- University Hospital Basel
-
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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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy subjects
Description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- acute illness
- chronic illness
- pregnancy
- Anemia defined as Hb < 30g/l
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
observational
Blood samples will be taken for measuring copeptin levels in healthy subjects.
|
blood sampling during 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of copeptin values in mmol/l within 24 hours to assess the amount of release in a day curve.
Time Frame: 24 hours
|
The primary outcome measure is to compare the copeptin concentration in the early afternoon and the early morning by blood sampling at different time points.
Evaluation of the question if there is a circadian rhythm in the copeptin release.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mirjam Christ-Crain, MD, Prof., University Hospital, Basel, Switzerland
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
November 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
November 10, 2015
First Submitted That Met QC Criteria
November 13, 2015
First Posted (Estimate)
November 16, 2015
Study Record Updates
Last Update Posted (Estimate)
August 15, 2016
Last Update Submitted That Met QC Criteria
August 12, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ 2015-266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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