Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Copeptin in the Diagnosis and Differential Diagnosis of Diabetes Insipidus. The CoSIP-Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00757276
First received: September 22, 2008
Last updated: April 4, 2013
Last verified: April 2013

September 22, 2008
April 4, 2013
June 2008
June 2013   (final data collection date for primary outcome measure)
Diagnosis of diabetes insipidus(DI) centralis versus psychogenic DI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00757276 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Copeptin in the Diagnosis and Differential Diagnosis of Diabetes Insipidus. The CoSIP-Study
Copeptin in the Diagnosis and Differential Diagnosis of Diabetes Insipidus. The CoSIP-Study

Evaluation of Copeptin in the differential diagnosis of diabetes insipidus.

Background:

Plasma AVP measurement is recommended for the differential diagnosis of diabetes insipidus and polydipsia. However, AVP measurement is cumbersome. AVP is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of AVP. Copeptin can be assayed readily in plasma.

Aim: To evaluate the diagnostic accuracy of copeptin levels in the diagnosis and differential diagnosis of diabetes insipidus.

Design: Prospective, observational multicenter study.

Setting: Department of Endocrinology, University Hospital of Basel

Patients: Patients with suspected or known central (complete or partial), nephrogenic (complete or partial) or psychogenic diabetes insipidus undergoing a standardized water deprivation test.

Intervention: All patients with suspected or known diabetes insipidus will undergo an overnight water deprivation test and a standardized water deprivation test, as routinely performed in the diagnostic evaluation of diabetes insipidus. Plasma AVP and copeptin will be measured at baseline (8 am before start of thirsting), and hourly during the water deprivation test.

Study hypothesis: Copeptin levels will provide a better diagnostic accuracy in the diagnosis and differential diagnosis of diabetes insipidus as compared to AVP measurement.

Analysis: We will study 5 groups of patients: A) Patients with complete central diabetes insipidus, B) Patients with partial central diabetes insipidus, C) Patients with complete nephrogenic diabetes insipidus, D) Patients with partial nephrogenic diabetes insipidus and E) Patients with psychogenic diabetes insipidus. All groups will consist of 10 patients based on the following assumptions: Based on pilot studies we assume that patients in group A) will have copeptin values of 2.5 ± 1.0; Group B) 3.0 ± 1.0, Group C) 15.0 ± 5; Group D) 6 ± 2.0 and Group E) 4.0 ± 1.0 pmol/L. This results in a power of 90% to detect a difference in copeptin levels of 0.8pmol/L between the closest two groups, i.e. patients with partial central Diabetes insipidus and patients with psychogenic Diabetes insipidus.

Significance: The measurement of copeptin will allow a better discrimination of patients with diabetes insipidus, especially for the discrimination of partial central and nephrogenic and psychogenic diabetes insipidus.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

bood sampling

Probability Sample

All patients >18 years who are tested for the diagnosis of DI because of a history of polyuria (>40ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis.

Diabetes Insipidus
Not Provided
1

All patients > 18 years who are tested for the diagnosis of DI because of a history of polyuria (> 40 ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis.

The investigators hypothesize that basal copeptin levels can reliably differentiate between the 5 groups(central, nephrogenic, psychogenic and partial forms) with a sensitivity and specificity >80%.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients > 18 years who are tested for the diagnosis of DI because of a history of polyuria (> 40 ml/kg per 24 hours) in the presence of polydipsia Patients with known DI will be contacted whether they agree to participate in the study and to undergo again a water deprivation test to measure copeptin to confirm the diagnosis.

Exclusion Criteria:

  • Polyuria of other origin, i.e. prostate hyperplasia, diabetes mellitus.
  • Pregnancy
  • The investigators do not perform the water deprivation test in patients with: *renal insufficiency

    • uncontrolled diabetes mellitus
    • hypovolemia of any cause
    • uncorrected deficiency of adrenal or thyroid hormones
  • No informed consent
Both
18 Years and older
No
Switzerland
 
NCT00757276
EKBB 68/08
Not Provided
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Mira Katan, Dr. MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP