Celiac Disease in Children, Diabetes Mellitus, Type I, Screening
Conditions
Brief summary
Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.
Interventions
DIAGNOSTIC_TESTTest on blood sample
The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.
DIAGNOSTIC_TESTTest on dried blood sample
A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)
Sponsors
Meyer Children's Hospital IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 2-13 years * Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls) * Obtained informed consent
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml | Baseline |
| Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml | Baseline |
| Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml | Baseline |
| Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml | Baseline |
| Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes | Baseline |
Countries
Italy
Contacts
Primary ContactChiara Azzari
Outcome results
None listed