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| Sponsored by: |
University Hospital, Basel, Switzerland |
|---|---|
| Information provided by: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00757276 |
Purpose
Evaluation of Copeptin in the differential diagnosis of diabetes insipidus.
| Condition |
|---|
|
Diabetes Insipidus Diagnosis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Copeptin in the Diagnosis and Differential Diagnosis of Diabetes Insipidus. The CoSIP-Study |
bood sampling
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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%.
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Background:
Plasma AVP measurement is recommended for the differential diagnosis of diabetes insipidus and polydipsia. However, AVP measurement is cumbersome. AVP is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of AVP. Copeptin can be assayed readily in plasma.
Aim: To evaluate the diagnostic accuracy of copeptin levels in the diagnosis and differential diagnosis of diabetes insipidus.
Design: Prospective, observational multicenter study.
Setting: Department of Endocrinology, University Hospital of Basel
Patients: Patients with suspected or known central (complete or partial), nephrogenic (complete or partial) or psychogenic diabetes insipidus undergoing a standardized water deprivation test.
Intervention: All patients with suspected or known diabetes insipidus will undergo an overnight water deprivation test and a standardized water deprivation test, as routinely performed in the diagnostic evaluation of diabetes insipidus. Plasma AVP and copeptin will be measured at baseline (8 am before start of thirsting), and hourly during the water deprivation test. Study hypothesis: Copeptin levels will provide a better diagnostic accuracy in the diagnosis and differential diagnosis of diabetes insipidus as compared to AVP measurement.
Analysis: We will study 5 groups of patients: A) Patients with complete central diabetes insipidus, B) Patients with partial central diabetes insipidus, C) Patients with complete nephrogenic diabetes insipidus, D) Patients with partial nephrogenic diabetes insipidus and E) Patients with psychogenic diabetes insipidus. All groups will consist of 10 patients based on the following assumptions: Based on pilot studies we assume that patients in group A) will have copeptin values of 2.5 ± 1.0; Group B) 3.0 ± 1.0, Group C) 15.0 ± 5; Group D) 6 ± 2.0 and Group E) 4.0 ± 1.0 pmol/L. This results in a power of 90% to detect a difference in copeptin levels of 0.8pmol/L between the closest two groups, i.e. patients with partial central Diabetes insipidus and patients with psychogenic Diabetes insipidus.
Significance: The measurement of copeptin will allow a better discrimination of patients with diabetes insipidus, especially for the discrimination of partial central and nephrogenic and psychogenic diabetes insipidus.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
The investigators do not perform the water deprivation test in patients with: *renal insufficiency
Contacts and Locations| Switzerland | |
| University Hospital Basel | Recruiting |
| Basel, Switzerland, 4031 | |
| Contact: Mira Katan, Dr. med. 0041 61265 2525 katanm@uhbs.ch | |
| Contact: Mirjam Christ-Crain, PD. Dr. med. 0041 61 265 252 25 mirjam.Christ-Crain@uhnibas.ch | |
| Principal Investigator: Mira Katan, Dr.med. | |
| Principal Investigator: Mirjam Christ-Crain, PD. Dr. med. | |
More Information
| Responsible Party: | University Hospital, Basel, Switzerland ( PD.Dr. med. M. Christ-Crain ) |
| Study ID Numbers: | EKBB 68/08 |
| Study First Received: | September 22, 2008 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00757276 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
Copeptin Diabetes insipidus diagnostic marker Vasopressin ADH |
|
Arginine Vasopressin Metabolic Diseases Pituitary Diseases Urologic Diseases Diabetes Insipidus Vasopressins |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Kidney Diseases Glucose Metabolism Disorders Metabolic Disorder |
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Metabolic Diseases Pituitary Diseases Urologic Diseases Diabetes Insipidus |
Diabetes Mellitus Endocrine System Diseases Kidney Diseases Glucose Metabolism Disorders |
