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Copeptin in Differentiation of Polyuria and Polydipsia
| Tracking Information | |||
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| First Received Date ICMJE | January 25, 2010 | ||
| Last Updated Date | April 22, 2011 | ||
| Start Date ICMJE | March 2008 | ||
| Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | Complete list of historical versions of study NCT01056887 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Copeptin in Differentiation of Polyuria and Polydipsia | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | The differential diagnosis of patients with polyuria/ polydipsia is often complex, but important for the therapeutic strategy. Challenging is in particular the clinical differentiation between patients with a partial Diabetes insipidus centralis and patients with primary polydipsia as underlying disease, because both groups are associated with similar urinary osmolalities. The determination of plasma arginine vasopressin is unusual in this context, since measurement of AVP is not reliably. C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the neurohypophysis, but has a longer half life in the circulation, and is thus easier to measure. Therefore, the investigators will analyze in that study the diagnostic utility of plasma copeptin in the differential diagnosis of polyuria and polydipsia. |
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| Detailed Description | Not Provided | ||
| Study Type ICMJE | Observational | ||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Probability Sample | ||
| Study Population | Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia | ||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Primary Polydip, D. insipidus | ||
| Publications * | Fenske W, Quinkler M, Lorenz D, Zopf K, Haagen U, Papassotiriou J, Pfeiffer AF, Fassnacht M, Störk S, Allolio B. Copeptin in the differential diagnosis of the polydipsia-polyuria syndrome--revisiting the direct and indirect water deprivation tests. J Clin Endocrinol Metab. 2011 May;96(5):1506-15. doi: 10.1210/jc.2010-2345. Epub 2011 Mar 2. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Estimated Enrollment ICMJE | 50 | ||
| Completion Date | November 2010 | ||
| Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Senior) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Germany | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01056887 | ||
| Other Study ID Numbers ICMJE | 17121979 33/07 |
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| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Prof. Dr. med. Bruno Allolio, FDAAA | ||
| Study Sponsor ICMJE | University of Wuerzburg | ||
| Collaborators ICMJE | Dr. Carson Liu Med Corp. | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | University of Wuerzburg | ||
| Verification Date | November 2010 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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