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Copeptin in Differentiation of Polyuria and Polydipsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01056887
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : April 25, 2011
Sponsor:
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
Change History
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.

*   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