Screening children with celiac disease for early signs of type 1 diabetes
Checks children with celiac disease for blood markers linked to type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients
Key facts
- Where
- Bari, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 1 to 18 years with celiac disease confirmed by a biopsy. They are tested for type 1 diabetes antibodies.
- Age
- 1 to 18 years
- Sex
- Boys and girls can both join.
- Disease stage
- Celiac disease confirmed by a biopsy.
- Earlier treatment
- People on immunosuppressive therapy cannot join.
Main reasons for not taking part
- Known type 1 diabetes
- Other autoimmune hormone gland diseases
- Immunosuppressive therapy
Read by machine on 13 November 2026.
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, ItalyContact: Fernanda CristoforiTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.