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

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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.

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.

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
We found this trial at
1
site
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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