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Use of Copeptin in Diabetes Insipidus

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland Identifier:
First received: September 9, 2013
Last updated: January 9, 2017
Last verified: January 2017
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.

Condition Intervention
Diabetes Insipidus (Central and Nephrogen)
Primary Polydipsia
Other: Water deprivation test
Other: Water deprivationtest
Other: Hypertonic saline infusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Discriminative value of copeptin during different diagnostic tests. [ Time Frame: beginning and end of protocol, up to 8hours ]

Estimated Enrollment: 140
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Water deprivation test
    Classical water deprivation test alone
    Other: Water deprivationtest
    classical water deprivation test plus plasma copeptin cut-off levels
    Other: Hypertonic saline infusion
    hypertonic saline infusion test plus plasma copeptin measurement
Detailed Description:

Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogen) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.

The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care center

Inclusion Criteria:

  • Polyuria or/and Polydipsia or/and therapy with synthetic AVP derivate
  • Urine osmolality <800mOsm/kgH20

Exclusion Criteria:

  • Polyuria due to diabetes mellitus
  • Hypokalemia
  • Hyperkalemia (>5mmol/l)
  • Hypercalcemia
  • Kidney disease (min.: GFR 60ml/min/1.73m2)
  • Pregnancy
  • Hyponatremia >135mmol/L
  • Hypernatremia >145mmol/L
  • Hypo- or hypervolemia
  • uncorrected adrenal or thyroidal deficiency
  • Cardia failure
  • Epilepsia
  • Uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01940614

Contact: Mirjam Christ-Crain, Prof. Dr. med. 0041 61 265 2525

Univerisity Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Mirjam Christ-Crain, Prof. Dr. med.    +41612652525      
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Mirjam Christ-Crain University Hospital
  More Information

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01940614     History of Changes
Other Study ID Numbers: CODDI2013
Study First Received: September 9, 2013
Last Updated: January 9, 2017

Keywords provided by University Hospital, Basel, Switzerland:
differential diagnosis of polyuria polydipsia syndrome
diabetes insipidus
compulsive water drinking
water deprivation test

Additional relevant MeSH terms:
Diabetes Insipidus
Diabetes Mellitus
Polydipsia, Psychogenic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Pathologic Processes
Signs and Symptoms
Behavioral Symptoms
Neurobehavioral Manifestations
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 25, 2017