Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Joslin Diabetes Center
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change in Markers of Autoimmunity
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Celiac Disease and T1D Sham Challenge
Intervention: Sham Challenge (Dietary Supplement)
Celiac Disease Alone Gluten Challenge
Intervention: Gluten Challenge (Dietary Supplement)
Celiac Disease Alone Sham Challenge
Intervention: Sham Challenge (Dietary Supplement)
Celiac Disease and T1D Gluten Challenge
Intervention: Gluten Challenge (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Markers of Autoimmunity
Time Frame: Baseline and day 3 post challenge
Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.
Secondary Outcomes
- Gastrointestinal Symptoms(Baseline and 6 days)
Investigators
Jason Gaglia
Assistant Investigator
Joslin Diabetes Center