- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932476
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
-
-
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
|
Three-day gluten containing dietary challenge.
|
Sham Comparator: Celiac Disease Alone Sham Challenge
|
Three-day sham (gluten free) dietary challenge
|
Experimental: Celiac Disease and T1D Gluten Challenge
|
Three-day gluten containing dietary challenge.
|
Sham Comparator: Celiac Disease and T1D 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
Collaborators
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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