NCT01056887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 25, 2011

Status Verified

November 1, 2010

Enrollment Period

2.7 years

First QC Date

January 25, 2010

Last Update Submit

April 22, 2011

Conditions

Keywords

diabetes insipidusprimary polydipsiacopeptinUtility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test

Study Arms (1)

Primary Polydip, D. insipidus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia

You may qualify if:

  • Patients with polydipsia/ polyuria, with indication for performing a deprivation test
  • \> 18 years

You may not qualify if:

  • dDAVP during the last 14d
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (1)

  • Fenske W, Quinkler M, Lorenz D, Zopf K, Haagen U, Papassotiriou J, Pfeiffer AF, Fassnacht M, Stork 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.

MeSH Terms

Conditions

PolyuriaPolydipsiaDiabetes InsipidusPolydipsia, Psychogenic

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesKidney DiseasesPituitary DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

March 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 25, 2011

Record last verified: 2010-11

Locations