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Use of Copeptin in Diabetes Insipidus

This study is currently recruiting participants.
Verified January 2017 by University Hospital, Basel, Switzerland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01940614
First Posted: September 12, 2013
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
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).

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
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


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

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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01940614     History of Changes
Other Study ID Numbers: CODDI2013
First Submitted: September 9, 2013
First Posted: September 12, 2013
Last Update Posted: January 10, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Insipidus
Polydipsia
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
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs