Use of Copeptin in Diabetes Insipidus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Diabetes Insipidus Primary Polydipsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Water deprivation test

Classical water deprivation test alone

Intervention Type OTHER

Water deprivation test

classical water deprivation test plus plasma copeptin cut-off levels

Intervention Type OTHER

Hypertonic saline infusion

hypertonic saline infusion test plus plasma copeptin measurement

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No