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Copeptin During a Standardized Psychological Stress Test (PsyCo)

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ClinicalTrials.gov Identifier: NCT01866137
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.

Condition or disease
Stress

Detailed Description:
healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Copeptin During a Standardized Psychological Stress Test
Study Start Date : March 2013
Primary Completion Date : June 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
no treatment
no treatment


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
7.5 ml of EDTA blood, 7.5 ml of serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adults
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866137


Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mirjam Christ-Crain, Prof.Dr.med.
More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01866137     History of Changes
Other Study ID Numbers: PsyCo
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin
psychological stress
The Trier Social Stress Test (TSST)

Additional relevant MeSH terms:
Diabetes Insipidus
Stress, Psychological
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Behavioral Symptoms
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs