NCT01940614

Brief Summary

Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 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

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

September 9, 2013

Last Update Submit

April 12, 2018

Conditions

Diabetes InsipidusPrimary Polydipsia

Keywords

Copeptindifferential diagnosis of polyuria polydipsia syndromediabetes insipiduscompulsive water drinkingwater deprivation testDiabetes insipidus (central and nephrogenic)

Outcome Measures

Primary Outcomes (1)

  • 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

    beginning and end of protocol, up to 9hours

Secondary Outcomes (5)

  • Sensitivity, specificity, positive and negative predictive value

    beginning and end of protocol, up to 9hours

  • post-hoc best copeptin cut-off optimising overall performance

    beginning and end of protocol, up to 9hours

  • subjective burden as rated by patients on visual analogue scale

    beginning, during and end of protocol, up to 9hours

  • Predictive value of specific anamnestic and clinical features

    before tests

  • Predictive value of absent bright spot in posterior pituitary enlargement

    before or after tests

Interventions

Water deprivation testOTHER

Classical water deprivation test alone

Hypertonic saline infusionOTHER

hypertonic saline infusion test plus plasma copeptin measurement

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care center

You may qualify if:

  • Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
  • Urine osmolality \<800mOsm/kgH20

You may not qualify if:

  • Polyuria due to diabetes mellitus
  • Hypokalemia
  • Hyperkalemia (\>5mmol/l)
  • Hypercalcemia
  • Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
  • Pregnancy
  • Hyponatremia \>135mmol/L
  • Hypernatremia \>145mmol/L
  • Hypo- or hypervolemia
  • uncorrected adrenal or thyroidal deficiency
  • Cardia failure
  • Epilepsia
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 40294614DERIVED

  • Sailer 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.

    PMID: 33980941DERIVED

  • Fenske 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.

    PMID: 30067922DERIVED

MeSH Terms

Conditions

Diabetes InsipidusPolydipsia, Psychogenic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesPolydipsiaPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Mirjam Christ-Crain

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

CH(1)