NCT02604875

Brief Summary

The circadian rhythm of copeptin will be examined in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

November 10, 2015

Last Update Submit

August 12, 2016

Conditions

Circadian RhythmCopeptin Blood Levels

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Study Arms (1)

observational

Blood samples will be taken for measuring copeptin levels in healthy subjects.

Other: observation

Interventions

observationOTHER

blood sampling during 24 hours

observational

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects

You may qualify if:

  • healthy subjects

You may not qualify if:

  • acute illness
  • chronic illness
  • pregnancy
  • Anemia defined as Hb \< 30g/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Mirjam Christ-Crain, MD, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 16, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)