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CompletedNCT01932476Updated Apr 17, 2017

Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

An interventional study of Gluten Challenge and Sham Challenge in Type 1 Diabetes and Celiac Disease, sponsored by Joslin Diabetes Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-17.

Sponsored by Joslin Diabetes Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes
  • Celiac Disease
03

In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Joslin Diabetes Center is the lead sponsor of 79 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Celiac Disease Alone Gluten Challenge

    Dietary Supplement: Gluten Challenge

  • Sham comparator
    Celiac Disease Alone Sham Challenge

    Dietary Supplement: Sham Challenge

  • Experimental
    Celiac Disease and T1D Gluten Challenge

    Dietary Supplement: Gluten Challenge

  • Sham comparator
    Celiac Disease and T1D Sham Challenge

    Dietary Supplement: Sham Challenge

Interventions

  • Dietary supplementGluten Challenge

    Three-day gluten containing dietary challenge.

  • Dietary supplementSham Challenge

    Three-day sham (gluten free) dietary challenge

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Joslin Diabetes Center
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01932476
Lead sponsor
Joslin Diabetes Center
Collaborators
ImmusanT, Inc.
Responsible party
Jason Gaglia (Assistant Investigator, Joslin Diabetes Center) — Principal investigator
First posted
Aug 30, 2013
Start date
Aug 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 17, 2017

Study contacts

Jason Gaglia, MD, MMSc
principal investigator · Joslin Diabetes Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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