Copeptin in Differentiation of Polyuria and Polydipsia

• ClinicalTrials.gov Identifier: NCT01056887
• Recruitment Status: Completed
• First Posted: January 26, 2010
• Last Update Posted: April 25, 2011
• Sponsor: University of Wuerzburg
• Collaborator: Dr. Carson Liu Med Corp.
• Information provided by: University of Wuerzburg

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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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.

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

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