Skip to main content
OpenTrials
Completed

NCT Number: NCT01940614

Use of Copeptin in Diabetes Insipidus

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Insipidus Behavior Behavioral Symptoms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Polydipsia Polydipsia, Psychogenic Primary Polydipsia Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Univerisity Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Water deprivation test

Other

Classical water deprivation test alone

Hypertonic Saline Infusion

Other

hypertonic saline infusion test plus plasma copeptin measurement

Primary outcomes

  1. 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

Secondary outcomes

  1. Sensitivity, specificity, positive and negative predictive value

    Time frame: beginning and end of protocol, up to 9hours

    each diagnostic test

  2. post-hoc best copeptin cut-off optimising overall performance

    Time frame: beginning and end of protocol, up to 9hours

    best copeptin cut-offs for differentiation between different diagnosis of polyuria-polydipsia syndrome

  3. subjective burden as rated by patients on visual analogue scale

    Time frame: beginning, during and end of protocol, up to 9hours

    water deprivation test and hypertonic saline Infusion test

  4. Predictive value of specific anamnestic and clinical features

    Time frame: before tests

    Evaluation of anamnestic and clinical features to test-independently predict final diagnosis of polyuria-polydipsia syndrome

  5. Predictive value of absent bright spot in posterior pituitary enlargement

    Time frame: before or after tests

    Evaluation of predictive value of absent bright spot in T1 weighted cranial MRI scans

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2013
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.