Health TrialsbyHealthPanel

Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

ConditionsCeliac Disease in ChildrenDiabetes Mellitus, Type IScreening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-13
SponsorMeyer Children's Hospital IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

none

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test on blood sample

    Diagnostic test

    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.

  • Test on dried blood sample

    Diagnostic test

    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)

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Test on blood sample (diagnosis of celiac and diabetes disease)Other 1 intervention
Group B: test on dried blood spot (celiac and diabetes patients)Other 1 intervention

Trial outcomes

Primary outcomes

1

Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml

Time frame
Baseline

Secondary outcomes

1

Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml

Time frame
Baseline
2

Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml

Time frame
Baseline
3

Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml

Time frame
Baseline
4

Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meyer Children's Hospital IRCCS

Lead sponsor

Source ClinicalTrials.gov
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