Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Not Applicable

Completed

• Conditions: Celiac Disease; Type 1 Diabetes
• Interventions: Dietary Supplement: Gluten Challenge; Dietary Supplement: Sham Challenge

• Registration Number: NCT01932476
• Lead Sponsor: Joslin Diabetes Center

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celiac Disease and T1D Gluten Challenge	Gluten Challenge	-
Celiac Disease and T1D Sham Challenge	Sham Challenge	-
Celiac Disease Alone Gluten Challenge	Gluten Challenge	-
Celiac Disease Alone Sham Challenge	Sham Challenge	-

Primary Outcome Measures

Name	Time	Method
Change in Markers of Autoimmunity	Baseline and day 3 post challenge	Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptoms	Baseline and 6 days	Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States