Diabetes InsipidusNCT01940614
Use of Copeptin in Diabetes Insipidus
An observational study of Diabetes Insipidus and Primary Polydipsia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Diabetes Insipidus, Primary Polydipsia
- What is being tested?
- Water deprivation test and Hypertonic saline infusion
- Type of treatment
- Injection or infusion
- How many people
- 156 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Dec 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care center
Who may be able to join
- Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
- Urine osmolality <800mOsm/kgH20
Who cannot join
- Polyuria due to diabetes mellitus
- Hypokalemia
- Hyperkalemia (>5mmol/l)
- Hypercalcemia
- Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
- Pregnancy
Show all 13Show fewer
- Hyponatremia >135mmol/L
- Hypernatremia >145mmol/L
- Hypo- or hypervolemia
- uncorrected adrenal or thyroidal deficiency
- Cardia failure
- Epilepsia
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Univerisity Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.
Read the detailed description
Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.
The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).
- Conditions
- Diabetes Insipidus, Primary Polydipsia
- Being tested
- Water deprivation test, Hypertonic saline infusion
- Keywords
- Copeptin, differential diagnosis of polyuria polydipsia syndrome, diabetes insipidus, compulsive water drinking, water deprivation test, Diabetes insipidus (central and nephrogenic)
- Medical subject headings
- Diabetes Insipidus, Polydipsia, Psychogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water deprivation testOther
Classical water deprivation test alone
Water deprivation testOther
classical water deprivation test plus plasma copeptin cut-off levels
Hypertonic saline infusionOther
hypertonic saline infusion test plus plasma copeptin measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic accuracy
Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests:
- classical water deprivation test alone
- classical water deprivation test plus plasma copeptin cut-off levels
- hypertonic saline Infusion test plus plasma copeptin measurements
Measured: beginning and end of protocol, up to 9hours
Secondary outcomes (5)
Sensitivity, specificity, positive and negative predictive value
each diagnostic test
Measured: beginning and end of protocol, up to 9hours
post-hoc best copeptin cut-off optimising overall performance
best copeptin cut-offs for differentiation between different diagnosis of polyuria-polydipsia syndrome
Measured: beginning and end of protocol, up to 9hours
subjective burden as rated by patients on visual analogue scale
water deprivation test and hypertonic saline Infusion test
Measured: beginning, during and end of protocol, up to 9hours
Predictive value of specific anamnestic and clinical features
Evaluation of anamnestic and clinical features to test-independently predict final diagnosis of polyuria-polydipsia syndrome
Measured: before tests
Predictive value of absent bright spot in posterior pituitary enlargement
Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans
Measured: before or after tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes InsipidusStudies 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940614
- Sponsor's protocol ID
- CODDI2013
- Status last verified
- Apr 2018
- First submitted
- 9 Sep 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atila C, Chifu I, Drummond JB, Vogt DR, Nahum U, Fassnacht M, Winzeler B, Refardt J, Christ-Crain M. A novel diagnostic score for diagnosing arginine vasopressin deficiency (central diabetes insipidus) or primary polydipsia with basal laboratory and clinical parameters: results from two international multicentre prospective diagnostic studies. Lancet Diabetes Endocrinol. 2025 Jun;13(6):505-515. doi: 10.1016/S2213-8587(25)00053-1. Epub 2025 Apr 25.
PubMed 40294614Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
PubMed 33980941Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760.
PubMed 30067922
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
- ClinicalTrials.gov ID
- NCT01940614
- Acronym / sponsor ID
- CODDI2013
- Conditions
- Diabetes Insipidus, Primary Polydipsia
- Keywords
- Copeptin, differential diagnosis of polyuria polydipsia syndrome, diabetes insipidus, compulsive water drinking, water deprivation test, Diabetes insipidus (central and nephrogenic)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Sep 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.
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.
Detailed description
Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.
The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care center
Key inclusion criteria (2 listed)
- Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
- Urine osmolality <800mOsm/kgH20
Key exclusion criteria (13 listed)
- Polyuria due to diabetes mellitus
- Hypokalemia
- Hyperkalemia (>5mmol/l)
- Hypercalcemia
- Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water deprivation testClassical water deprivation test alone | Other | – |
| Water deprivation testclassical water deprivation test plus plasma copeptin cut-off levels | Other | – |
| Hypertonic saline infusionhypertonic saline infusion test plus plasma copeptin measurement | Other | – |
Primary outcome
Overall diagnostic accuracy
Time frame: beginning and end of protocol, up to 9hours
Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests: * classical water deprivation test alone * classical water deprivation test plus plasma copeptin cut-off levels * hypertonic saline Infusion test plus plasma copeptin measurements
5 secondary outcomes
Sensitivity, specificity, positive and negative predictive value
Time frame: beginning and end of protocol, up to 9hours
post-hoc best copeptin cut-off optimising overall performance
Time frame: beginning and end of protocol, up to 9hours
subjective burden as rated by patients on visual analogue scale
Time frame: beginning, during and end of protocol, up to 9hours
Predictive value of specific anamnestic and clinical features
Time frame: before tests
Predictive value of absent bright spot in posterior pituitary enlargement
Time frame: before or after tests
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 17 Apr 2018.
- Derived from this study: PubMed 40294614Atila C, Chifu I, Drummond JB, Vogt DR, Nahum U, Fassnacht M, Winzeler B, Refardt J, Christ-Crain M. A novel diagnostic score for diagnosing arginine vasopressin deficiency (central diabetes insipidus) or primary polydipsia with basal laboratory and clinical parameters: results from two international multicentre prospective diagnostic studies. Lancet Diabetes Endocrinol. 2025 Jun;13(6):505-515. doi: 10.1016/S2213-8587(25)00053-1. Epub 2025 Apr 25.
- Derived from this study: PubMed 33980941Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
- Derived from this study: PubMed 30067922Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760.
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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 principal investigator
University Hospital
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 Diabetes Insipidus and Primary Polydipsia, 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 13 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 17 Apr 2018. 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?
Overall diagnostic accuracy (time frame: beginning and end of protocol, up to 9hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01940614, which also lists 3 linked publications.
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 17 Apr 2018.