Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01932476

Enrollment

Registered

2013-08-30

Start date

2013-08-31

Completion date

2014-12-31

Last updated

2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes, Celiac Disease

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.

Interventions

DIETARY_SUPPLEMENTGluten Challenge

Three-day gluten containing dietary challenge.

DIETARY_SUPPLEMENTSham Challenge

Three-day sham (gluten free) dietary challenge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026