Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Use of Copeptin in Diabetes Insipidus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01940614
First received: September 9, 2013
Last updated: September 12, 2013
Last verified: September 2013
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med. University Hospital
  More Information

No publications provided

Responsible Party: Mirjam Christ-Crain, Pfor.Dr.med, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01940614     History of Changes
Other Study ID Numbers: CODDI2013
Study First Received: September 9, 2013
Last Updated: September 12, 2013
Health Authority: Switzerland: Ethikkommission

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 Insipidus
Diabetes Insipidus, Neurogenic
Diabetes Mellitus
Polydipsia
Polydipsia, Psychogenic
Behavioral Symptoms
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Neurobehavioral Manifestations
Pathologic Processes
Pituitary Diseases
Signs and Symptoms
Urologic Diseases
Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014