Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients
Key facts
- Where
- Bari, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT07862101, who can take part
Where in Italy
- University Of Bari Aldo Moro-Pediatric Gastroenterology SectionBari, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Bari
- Trial code
- NCT07862101
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
Celiac Autoimmunity and Risk Evaluation Strategies for Type 1 Diabetes in Pediatric Patients
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.
Inclusion: Children aged 1-18 years with biopsy-confirmed CD; Informed consent from parents/legal guardians and assent from the child (as applicable).
Exclusion: • Known diagnosis of type 1 diabetes; Other autoimmune endocrinopathies or immunosuppressive therapy.