Copeptin in Differentiation of Polyuria and Polydipsia

Tracking Information
First Submitted Date	January 25, 2010
First Posted Date	January 26, 2010
Last Update Posted Date	April 25, 2011
Study Start Date	March 2008
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01056887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Copeptin in Differentiation of Polyuria and Polydipsia
Official Title	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
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	Polyuria; Polydipsia
Intervention	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: January 25, 2010)	50
Original Estimated Enrollment	Same as current
Actual Study Completion Date	November 2010
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Patients with polydipsia/ polyuria, with indication for performing a deprivation test; > 18 years Exclusion Criteria: dDAVP during the last 14d; pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Germany
Removed Location Countries
Administrative Information
NCT Number	NCT01056887
Other Study ID Numbers	17121979; 33/07
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	University of Wuerzburg
Collaborators	Dr. Carson Liu Med Corp.
Investigators	Not Provided
PRS Account	University of Wuerzburg
Verification Date	November 2010