PolyuriaNCT01056887
Copeptin in Differentiation of Polyuria and Polydipsia
An observational study of Polyuria and Polydipsia, run by University of Wuerzburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyuria, Polydipsia
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia
Who may be able to join
- Patients with polydipsia/ polyuria, with indication for performing a deprivation test
- > 18 years
Who cannot join
- dDAVP during the last 14d
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Polyuria, Polydipsia
- Keywords
- diabetes insipidus, primary polydipsia, copeptin, Utility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test
- Medical subject headings
- Polyuria, Polydipsia, Diabetes Insipidus, Polydipsia, Psychogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Polydip, D. insipidus | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolyuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Carson Liu Med Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056887
- Sponsor's protocol ID
- 17121979
- Other IDs
- 33/07
- Status last verified
- Nov 2010
- First submitted
- 25 Jan 2010
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21367924
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin in Differentiation of Polyuria and Polydipsia
- ClinicalTrials.gov ID
- NCT01056887
- Acronym / sponsor ID
- 17121979
- Conditions
- Polyuria, Polydipsia
- Keywords
- diabetes insipidus, primary polydipsia, copeptin, Utility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- Dr. Carson Liu Med Corp.
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Polydip, D. insipidus | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia
Key inclusion criteria (2 listed)
- Patients with polydipsia/ polyuria, with indication for performing a deprivation test
- > 18 years
Key exclusion criteria (2 listed)
- dDAVP during the last 14d
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Derived from this study: PubMed 21367924Fenske 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyuria and Polydipsia, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2011.