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The Circadian Rhythm of Copeptin (Co-Rhythm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02604875
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date November 10, 2015
First Posted Date November 16, 2015
Last Update Posted Date August 15, 2016
Study Start Date November 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Circadian Rhythm of Copeptin
Official Title The Circadian Rhythm of Copeptin
Brief Summary The circadian rhythm of copeptin will be examined in healthy subjects.
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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population healthy subjects
Condition
  • Circadian Rhythm
  • Copeptin Blood Levels
Intervention Other: observation
blood sampling during 24 hours
Study Groups/Cohorts observational
Blood samples will be taken for measuring copeptin levels in healthy subjects.
Intervention: Other: observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2015)
18
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • acute illness
  • chronic illness
  • pregnancy
  • Anemia defined as Hb < 30g/l
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02604875
Other Study ID Numbers EKNZ 2015-266
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Mirjam Christ-Crain, MD, Prof. University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date August 2016