Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

Inclusion Criteria:

1. Males and females 5-17 years of age

2. Full-sibling of an individual with a clinical diagnosis of type 1 diabetes

3. Treatment naïve of any immunomodulatory agent

4. HLA haplotype other than high-risk haplotype of DR3/DR4

5. Absence of type 1 diabetes autoantibodies

Exclusion Criteria:

1. Abnormal HbA1c, defined as ≥ 6%

2. Previous or current use of a gluten-free diet

3. Current diagnosis of celiac disease

4. An elevated tissue transglutaminase IgA level (> 10 units/mL)

5. Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal
symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation,
diarrhea, or recurrent nausea +/- vomiting)

6. Chronic inflammatory or autoimmune disease with the exception of well-controlled
hypothyroidism or intermittent or mild persistent asthma not requiring the use of
daily inhaled steroids

7. Use of any medications that affect glucose metabolism (e.g., metformin) or the immune
system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous)
within the previous 3 months)

8. Use of any medications that could affect intestinal microbiota within the previous 3
months (e.g., antibiotics, prebiotics, or probiotics)

9. Any condition that, in the investigator's opinion, may compromise study participation
or may confound the interpretation of the study results