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Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Primary Purpose

Type 1 Diabetes, Celiac Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gluten Challenge

Sham Challenge

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Joslin Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Celiac Disease Alone Gluten Challenge

Celiac Disease Alone Sham Challenge

Celiac Disease and T1D Gluten Challenge

Celiac Disease and T1D Sham Challenge

Arm Description

Outcomes

Primary Outcome Measures

Change in Markers of Autoimmunity

Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.

Secondary Outcome Measures

Gastrointestinal Symptoms

Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.

Full Information

NCT ID

NCT01932476

First Posted

August 14, 2013

Last Updated

April 13, 2017

Sponsor

Joslin Diabetes Center

Collaborators

ImmusanT, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01932476

Brief Title

Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (Actual)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Joslin Diabetes Center

Collaborators

ImmusanT, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Celiac Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celiac Disease Alone Gluten Challenge

Arm Type

Experimental

Arm Title

Celiac Disease Alone Sham Challenge

Arm Type

Sham Comparator

Arm Title

Celiac Disease and T1D Gluten Challenge

Arm Type

Experimental

Arm Title

Celiac Disease and T1D Sham Challenge

Arm Type

Sham Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Gluten Challenge

Intervention Description

Three-day gluten containing dietary challenge.

Intervention Type

Dietary Supplement

Intervention Name(s)

Sham Challenge

Intervention Description

Three-day sham (gluten free) dietary challenge

Primary Outcome Measure Information:

Title

Change in Markers of Autoimmunity

Description

Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.

Time Frame

Baseline and day 3 post challenge

Secondary Outcome Measure Information:

Title

Gastrointestinal Symptoms

Description

Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.

Time Frame

Baseline and 6 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Gaglia, MD, MMSc

Organizational Affiliation

Joslin Diabetes Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Joslin Diabetes Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

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