Diabetes Insipidus Clinical Trial
Official title:
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 arginine vasopressin (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 Model: Cohort, Time Perspective: Prospective
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