Copeptin in the Diagnosis and Differential Diagnosis of Diabetes Insipidus. The CoSIP-Study

NCT00757276 | Completed

• 1 other identifier: EKBB 68/08
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Copeptin in the differential diagnosis of diabetes insipidus.

Conditions

Diabetes Insipidus

Keywords

Copeptin; Diabetes insipidus; diagnostic marker; Vasopressin; antidiuretic hormone (ADH)

Outcome Measures

Primary Outcomes (1)

• Diagnosis of diabetes insipidus(DI) centralis versus psychogenic DI

  2 years

Study Arms (1)

1

All patients \> 18 years who are tested for the diagnosis of DI because of a history of polyuria (\> 40 ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis. The investigators hypothesize that basal copeptin levels can reliably differentiate between the 5 groups(central, nephrogenic, psychogenic and partial forms) with a sensitivity and specificity \>80%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients \>18 years who are tested for the diagnosis of DI because of a history of polyuria (\>40ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis.

You may qualify if:

• All patients \> 18 years who are tested for the diagnosis of DI because of a history of polyuria (\> 40 ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis.

You may not qualify if:

• Polyuria of other origin, i.e. prostate hyperplasia, diabetes mellitus.
• Pregnancy
• The investigators do not perform the water deprivation test in patients with: \*renal insufficiency
• uncontrolled diabetes mellitus
• hypovolemia of any cause
• uncorrected deficiency of adrenal or thyroid hormones
• No informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Related Publications (6)

• Atila C, Winzeler B, Chifu I, Fassnacht M, Refardt J, Christ-Crain M. A post-hoc internal validation of arginine-stimulated copeptin cut-offs for diagnosing AVP deficiency (central diabetes insipidus). Pituitary. 2025 Apr 26;28(3):53. doi: 10.1007/s11102-025-01523-2.

  PMID: 40281371 DERIVED

• Ebrahimi F, Urwyler SA, Betz MJ, Christ ER, Schuetz P, Mueller B, Donath MY, Christ-Crain M. Effects of interleukin-1 antagonism and corticosteroids on fibroblast growth factor-21 in patients with metabolic syndrome. Sci Rep. 2021 Apr 12;11(1):7911. doi: 10.1038/s41598-021-87207-w.

  PMID: 33846498 DERIVED

• Bologna K, Cesana-Nigro N, Refardt J, Imber C, Vogt DR, Christ-Crain M, Winzeler B. Effect of Arginine on the Hypothalamic-Pituitary-Adrenal Axis in Individuals With and Without Vasopressin Deficiency. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa157. doi: 10.1210/clinem/dgaa157.

  PMID: 32236441 DERIVED

• Winzeler B, Cesana-Nigro N, Refardt J, Vogt DR, Imber C, Morin B, Popovic M, Steinmetz M, Sailer CO, Szinnai G, Chifu I, Fassnacht M, Christ-Crain M. Arginine-stimulated copeptin measurements in the differential diagnosis of diabetes insipidus: a prospective diagnostic study. Lancet. 2019 Aug 17;394(10198):587-595. doi: 10.1016/S0140-6736(19)31255-3. Epub 2019 Jul 11.

  PMID: 31303316 DERIVED

• Urwyler SA, Timper K, Fenske W, de Mota N, Blanchard A, Kuhn F, Frech N, Arici B, Rutishauser J, Kopp P, Stettler C, Muller B, Katan M, Llorens-Cortes C, Christ-Crain M. Plasma Apelin Concentrations in Patients With Polyuria-Polydipsia Syndrome. J Clin Endocrinol Metab. 2016 May;101(5):1917-23. doi: 10.1210/jc.2016-1158. Epub 2016 Mar 11.

  PMID: 26967692 DERIVED

• Timper K, Fenske W, Kuhn F, Frech N, Arici B, Rutishauser J, Kopp P, Allolio B, Stettler C, Muller B, Katan M, Christ-Crain M. Diagnostic Accuracy of Copeptin in the Differential Diagnosis of the Polyuria-polydipsia Syndrome: A Prospective Multicenter Study. J Clin Endocrinol Metab. 2015 Jun;100(6):2268-74. doi: 10.1210/jc.2014-4507. Epub 2015 Mar 13.

  PMID: 25768671 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

bood sampling

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

CH (1)