Copeptin During a Standardized Psychological Stress Test | NCT01866137

Studies
Copeptin During a Standardized Psychological Stress Test

NCT01866137

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 9, 2014Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Stress

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

May 13, 2013

First Submission Date that Met QC Criteria

May 27, 2013

First Posted Date

May 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Label	Type	Description	Intervention Names
no treatment		no treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

healthy adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirjam Christ-Crain, Prof.Dr.med.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003919	Diabetes Insipidus
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided