Circadian RhythmCo-RhythmNCT02604875
The Circadian Rhythm of Copeptin
An observational study of Circadian Rhythm and Copeptin Blood Levels, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The circadian rhythm of copeptin will be examined in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm, Copeptin Blood Levels
- What is being tested?
- observation
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy subjects
Who may be able to join
- healthy subjects
Who cannot join
- acute illness
- chronic illness
- pregnancy
- Anemia defined as Hb < 30g/l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
The circadian rhythm of copeptin will be examined in healthy subjects.
Read the 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.
- Conditions
- Circadian Rhythm, Copeptin Blood Levels
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
blood sampling during 24 hours
| Study group | Role | What they receive |
|---|---|---|
| observational | Blood samples will be taken for measuring copeptin levels in healthy subjects. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of copeptin values in mmol/l within 24 hours to assess the amount of release in a day curve.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, MD, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604875
- Sponsor's protocol ID
- EKNZ 2015-266
- Acronym
- Co-Rhythm
- Status last verified
- Aug 2016
- First submitted
- 10 Nov 2015
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Circadian Rhythm of Copeptin
- ClinicalTrials.gov ID
- NCT02604875
- Acronym / sponsor ID
- Co-Rhythm / EKNZ 2015-266
- Conditions
- Circadian Rhythm, Copeptin Blood Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | Other: observationBlood samples will be taken for measuring copeptin levels in healthy subjects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy subjects
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (4 listed)
- acute illness
- chronic illness
- pregnancy
- Anemia defined as Hb < 30g/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationblood sampling during 24 hours | Other | observational |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, MD, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm and Copeptin Blood Levels, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of copeptin values in mmol/l within 24 hours to assess the amount of release in a day curve. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.