Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Joslin Diabetes Center

Status: Completed

Conditions: Celiac Disease; Type 1 Diabetes

Treatments: Dietary Supplement: Sham Challenge; Dietary Supplement: Gluten Challenge

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01932476

GC001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 4 patient groups

Celiac Disease Alone Gluten Challenge

Experimental group

Treatment:

Dietary Supplement: Gluten Challenge

Celiac Disease Alone Sham Challenge

Sham Comparator group

Treatment:

Dietary Supplement: Sham Challenge

Celiac Disease and T1D Gluten Challenge

Experimental group

Treatment:

Dietary Supplement: Gluten Challenge

Celiac Disease and T1D Sham Challenge

Sham Comparator group

Treatment:

Dietary Supplement: Sham Challenge