Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 1 Diabetes, Celiac Disease

Intervention / Treatment
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* Dietary Supplement: Gluten Challenge
* Dietary Supplement: Sham Challenge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celiac Disease Alone Gluten Challenge<br> | Dietary Supplement: Gluten Challenge<br>* Three-day gluten containing dietary challenge.<br>|
| Sham Comparator: Celiac Disease Alone Sham Challenge<br> | Dietary Supplement: Sham Challenge<br>* Three-day sham (gluten free) dietary challenge<br>|
| Experimental: Celiac Disease and T1D Gluten Challenge<br> | Dietary Supplement: Gluten Challenge<br>* Three-day gluten containing dietary challenge.<br>|
| Sham Comparator: Celiac Disease and T1D Sham Challenge<br> | Dietary Supplement: Sham Challenge<br>* Three-day sham (gluten free) dietary challenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Markers of Autoimmunity | Blood samples for markers of autoimmunity will be taken before and day 3 post challenge. | Baseline and day 3 post challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptoms | Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge. | Baseline and 6 days |