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Use of Copeptin in Diabetes Insipidus

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ClinicalTrials.gov Identifier: NCT01940614
Recruitment Status : Recruiting
First Posted : September 12, 2013
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.

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

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).

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01940614     History of Changes
Other Study ID Numbers: CODDI2013
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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 Mellitus
Diabetes Insipidus
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