Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

April 13, 2017 updated by: Jason Gaglia, Joslin Diabetes Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celiac Disease Alone Gluten Challenge
Dietary supplement: Gluten Challenge
Three-day gluten containing dietary challenge.
Sham Comparator: Celiac Disease Alone Sham Challenge
Dietary supplement: Sham Challenge
Three-day sham (gluten free) dietary challenge
Experimental: Celiac Disease and T1D Gluten Challenge
Dietary supplement: Gluten Challenge
Three-day gluten containing dietary challenge.
Sham Comparator: Celiac Disease and T1D Sham Challenge
Dietary supplement: Sham Challenge
Three-day sham (gluten free) dietary challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and day 3 post challenge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

ImmusanT, Inc.

Investigators

  • Principal Investigator: Jason Gaglia, MD, MMSc, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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