Use of Copeptin in Diabetes Insipidus

April 12, 2018 updated by: University Hospital, Basel, Switzerland

Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) 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

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Univerisity Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care center

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Polyuria due to diabetes mellitus
  • Hypokalemia
  • Hyperkalemia (>5mmol/l)
  • Hypercalcemia
  • Kidney disease (min.: glomerular filtration rate (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall diagnostic accuracy
Time Frame: beginning and end of protocol, up to 9hours

Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests:

  • classical water deprivation test alone
  • classical water deprivation test plus plasma copeptin cut-off levels
  • hypertonic saline Infusion test plus plasma copeptin measurements
beginning and end of protocol, up to 9hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive and negative predictive value
Time Frame: beginning and end of protocol, up to 9hours
each diagnostic test
beginning and end of protocol, up to 9hours
post-hoc best copeptin cut-off optimising overall performance
Time Frame: beginning and end of protocol, up to 9hours
best copeptin cut-offs for differentiation between different diagnosis of polyuria-polydipsia syndrome
beginning and end of protocol, up to 9hours
subjective burden as rated by patients on visual analogue scale
Time Frame: beginning, during and end of protocol, up to 9hours
water deprivation test and hypertonic saline Infusion test
beginning, during and end of protocol, up to 9hours
Predictive value of specific anamnestic and clinical features
Time Frame: before tests
Evaluation of anamnestic and clinical features to test-independently predict final diagnosis of polyuria-polydipsia syndrome
before tests
Predictive value of absent bright spot in posterior pituitary enlargement
Time Frame: before or after tests
Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans
before or after tests

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Mirjam Christ-Crain, University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODDI2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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