Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

N/ACompletedNCT01932476

Joslin Diabetes Center7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Type 1 Diabetes Celiac Disease

Interventions

Gluten ChallengeDIETARY_SUPPLEMENT

Three-day gluten containing dietary challenge.

Sham ChallengeDIETARY_SUPPLEMENT

Three-day sham (gluten free) dietary challenge

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Markers of Autoimmunity

Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.

Time frame: Baseline and day 3 post challenge

Secondary Outcomes

Gastrointestinal Symptoms

Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.

Time frame: Baseline and 6 days

Data from ClinicalTrials.gov

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