Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease, Endocrine, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 4/2/2016 |
Start Date: | August 2013 |
Contact: | Sarah Szubowicz, MPH |
Email: | sarah.szubowicz@joslin.harvard.edu |
Phone: | 617-309-4493 |
Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
The purpose of this study is to determine whether the immune response causing celiac disease
is related to the autoimmune response causing type-1 diabetes.
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 oral gluten challenge. This blood will be tested for biomarkers associated with
islet autoimmunity and gluten-specific cellular immunity.
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
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