NCT01866137

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

May 13, 2013

Last Update Submit

September 8, 2014

Conditions

Stress

Keywords

Copeptinpsychological stressThe Trier Social Stress Test (TSST)

Outcome Measures

Primary Outcomes (1)

  • Changes in copeptin levels after a psychological stress test in healthy volunteers

    30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test

Secondary Outcomes (1)

  • Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus

    Timpepoint 0, +10, +20, +40, +60 after the psychological stress test

Study Arms (1)

no treatment

no treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adults

You may qualify if:

  • Aged over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

7.5 ml of EDTA blood, 7.5 ml of serum

MeSH Terms

Conditions

Diabetes InsipidusStress, Psychological

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Mirjam Christ-Crain, Prof.Dr.med.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 31, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

February 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CH(1)