- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866137
Copeptin During a Standardized Psychological Stress Test (PsyCo)
September 8, 2014 updated by: University Hospital, Basel, Switzerland
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.
Study Overview
Status
Completed
Conditions
Detailed Description
healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured
Study Type
Observational
Enrollment (Actual)
20
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy adults
Description
Inclusion Criteria:
•Aged over 18 years
Exclusion Criteria:
- Intake of any kind of medication (except birth control pill)
- BMI >30 kg/m2
- Evidence of any acute illness
- History of chronic illness
- Baseline glucose level >7 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/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 |
|---|
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no treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in copeptin levels after a psychological stress test in healthy volunteers
Time Frame: 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test
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30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus
Time Frame: Timpepoint 0, +10, +20, +40, +60 after the psychological stress test
|
Timpepoint 0, +10, +20, +40, +60 after the psychological stress test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mirjam Christ-Crain, Prof.Dr.med.
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
March 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
May 13, 2013
First Submitted That Met QC Criteria
May 27, 2013
First Posted (Estimate)
May 31, 2013
Study Record Updates
Last Update Posted (Estimate)
September 9, 2014
Last Update Submitted That Met QC Criteria
September 8, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PsyCo
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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