NCT02647736

Brief Summary

Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Trial Health

85
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

September 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

December 23, 2015

Last Update Submit

August 2, 2016

Conditions

Copeptin Blood Values

Outcome Measures

Primary Outcomes (2)

  • Physiological relationship between Serum osmolality and Plasma copeptin release.

    Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l). Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states.

    beginning and end of protocol, up to 8 hours

  • Half life of Copeptin

    Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion)

    beginning and end of protocol, up to 8 hours

Study Arms (1)

Copeptin values in normo- to hyperosmolar states

EXPERIMENTAL
Other: Hypertonic saline infusion

Interventions

Hypertonic saline infusionOTHER
Copeptin values in normo- to hyperosmolar states

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Minimum Age 18
  • no severe comorbidities
  • no medication (except contraceptives)
  • baseline sodium Level 135-145mmol/l
  • euvolemic status

You may not qualify if:

  • history of heart failure
  • liver cirrhosis
  • kidney disease (GFR \<60ml/min)
  • anemia
  • uncontrolled Hypertension
  • pregnancy
  • Diabetes mellitus
  • BMI \>28kg/m2
  • other severe disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Würzburg

Würzburg, Germany

Location

University hospital Basel

Basel, Switzerland

Location

Related Publications (2)

  • Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.

    PMID: 33980941DERIVED

  • Fenske WK, Schnyder I, Koch G, Walti C, Pfister M, Kopp P, Fassnacht M, Strauss K, Christ-Crain M. Release and Decay Kinetics of Copeptin vs AVP in Response to Osmotic Alterations in Healthy Volunteers. J Clin Endocrinol Metab. 2018 Feb 1;103(2):505-513. doi: 10.1210/jc.2017-01891.

    PMID: 29267966DERIVED

Study Officials

  • Mirjam Christ-Crain, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

December 23, 2015

First Posted

January 6, 2016

Study Start

September 1, 2012

Primary Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

CH(1)DE(1)