Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients

Condition(s) studied

Study summary

Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset. International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet.

In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families.

Eligibility

Primary outcome measure(s)

• Screening of celiac paediatric patients — baseline
  The aim of the CARES-T1D project is to determine the prevalence of type 1 diabetes-associated autoantibodies (T1D) in pediatric subjects with CD to assess the frequency with which these immunologic biomarkers occur in this specific population. The plan is to screen all children in follow-up at our out-patient celiac clinic for diabetes specific autoantibodies. The parents will be informed about the study and invited to take part in the study during the scheduled appointment; a written informed consent will be signed by parents. The screening activity will be carried out over a 1-year period. It is expected that at least 80% of the parents will give their informed consent to participation in the study. Accordingly, about 480 celiac patients will be screened for the four biochemical autoantibodies predicting T1D, i.e. insulin autoantibodies (IAA)

Trial sites (1)

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