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Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water deprivation test | Other | Classical water deprivation test alone | ||
| Water deprivation test | Other | classical water deprivation test plus plasma copeptin cut-off levels | ||
| Hypertonic saline infusion | Other | hypertonic saline infusion test plus plasma copeptin measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Overall diagnostic accuracy | Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests:
| beginning and end of protocol, up to 9hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive and negative predictive value | each diagnostic test | beginning and end of protocol, up to 9hours |
| post-hoc best copeptin cut-off optimising overall performance |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care center
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Christ-Crain | University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40294614 | Derived | Atila C, Chifu I, Drummond JB, Vogt DR, Nahum U, Fassnacht M, Winzeler B, Refardt J, Christ-Crain M. A novel diagnostic score for diagnosing arginine vasopressin deficiency (central diabetes insipidus) or primary polydipsia with basal laboratory and clinical parameters: results from two international multicentre prospective diagnostic studies. Lancet Diabetes Endocrinol. 2025 Jun;13(6):505-515. doi: 10.1016/S2213-8587(25)00053-1. Epub 2025 Apr 25. | |
| 33980941 |
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| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D059607 | Polydipsia, Psychogenic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 | 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 | 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 | Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans | before or after tests |
| Derived |
| Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9. |
| 30067922 | Derived | Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D059606 | Polydipsia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |