Title
Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
Phase
N/ALead Sponsor
Joslin Diabetes CenterStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Type 1 Diabetes Celiac DiseaseIntervention/Treatment
gluten ...Study Participants
7The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.
Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.
Three-day gluten containing dietary challenge.
Three-day sham (gluten free) dietary challenge
Inclusion Criteria: Diagnosis of Celiac Disease by histology and serology For those with Type-1 Diabetes, at least one anti-islet antibody HLA-DQ2.5 genotype Exclusion Criteria: Not following a gluten free diet for at least 12 months Known gluten exposure within the prior 2 months Treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months Treatment with systemic immunomodulatory agents in prior 30 days Human immunodeficiency virus infection, untreated hepatitis B virus, or hepatitis C virus infection Nut allergy Hemoglobin level below normal range History of angina Pregnant or lactating Severe symptoms to gluten challenge in the past Elevation in transglutaminase-IgA or deamidated gliadin peptide IgA or IgG greater than or equal to 50% above upper limit of normal Uncontrolled complications of type-1 diabetes or celiac disease which pose a risk to participation
