HealthyNCT01879137
Copeptin After Arginine Infusion in Polyuria-Polydipsia Syndrome
An observational study of Healthy and Polyuria-polydipsia Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Polyuria-polydipsia Syndrome
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults Patients with polyuria-polydipsia syndrome
Who may be able to join
- Age over 18 years
- No medication except hormonal contraception
Who cannot join
- Evidence of any acute illness
- Subjects refusing or unable to give written informed consent
- Pregnancy
- Any evidence of disordered drinking habits and diuresis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Copeptin After Arginine Infusion for the Differential Diagnosis of the Polyuria-Polydipsia Syndrome ''The CARGO-Study''
the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.
- Conditions
- Healthy, Polyuria-polydipsia Syndrome
- Keywords
- Copeptin, Arginin stimulation test
- Medical subject headings
- Diabetes Insipidus
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 |
|---|---|---|
| healthy adults | Not described | |
| Patients with a polyuria-polydipsia syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminative value of copeptin after arginine infusion in the differential diagnosis of polyuria-polydipsia syndrome.
Measured: up to 120 minutes after the Arginine infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879137
- Sponsor's protocol ID
- CARGO 2013
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2013
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin After Arginine Infusion for the Differential Diagnosis of the Polyuria-Polydipsia Syndrome ''The CARGO-Study''
- ClinicalTrials.gov ID
- NCT01879137
- Acronym / sponsor ID
- CARGO 2013
- Conditions
- Healthy, Polyuria-polydipsia Syndrome
- Keywords
- Copeptin, Arginin stimulation test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Jun 2013 (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 purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy adults | – | – |
| Patients with a polyuria-polydipsia syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults Patients with polyuria-polydipsia syndrome
Key inclusion criteria (2 listed)
- Age over 18 years
- No medication except hormonal contraception
Key exclusion criteria (4 listed)
- Evidence of any acute illness
- Subjects refusing or unable to give written informed consent
- Pregnancy
- Any evidence of disordered drinking habits and diuresis
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
Discriminative value of copeptin after arginine infusion in the differential diagnosis of polyuria-polydipsia syndrome.
Time frame: up to 120 minutes after the Arginine infusion.
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 11 Jul 2017.
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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.
Mirjam Christ-Crain, Prof. MD principal investigator
University Hospital, Basel, Switzerland
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 Healthy and Polyuria-polydipsia Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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 11 Jul 2017. 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 Switzerland. 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.
What does the primary outcome measure?
Discriminative value of copeptin after arginine infusion in the differential diagnosis of polyuria-polydipsia syndrome. (time frame: up to 120 minutes after the Arginine infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017.