Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study

Summary

The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test.

The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%.

To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.

Conditions

• Diabetes Insipidus
• Polydipsia, Primary

Interventions

DIAGNOSTIC_TEST

Arginine infusion

Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion

DIAGNOSTIC_TEST

Hypertonic saline infusion

Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l

Sponsors & Collaborators

• University Hospital, Zürich

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Federal University of Minas Gerais

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Mirjam Christ-Crain, Prof, MD · University Hospital, Basel, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-03

Primary Completion

2022-09-30

Completion

2022-12-31

Countries

• Brazil
• Germany
• Italy
• Netherlands
• Switzerland
• United Kingdom

Study Locations