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
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 17, 2017
April 1, 2017
1.3 years
August 14, 2013
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Markers of Autoimmunity
Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.
Baseline and day 3 post challenge
Secondary Outcomes (1)
Gastrointestinal Symptoms
Baseline and 6 days
Study Arms (4)
Celiac Disease Alone Gluten Challenge
EXPERIMENTALCeliac Disease Alone Sham Challenge
SHAM COMPARATORCeliac Disease and T1D Gluten Challenge
EXPERIMENTALCeliac Disease and T1D Sham Challenge
SHAM COMPARATORInterventions
Three-day gluten containing dietary challenge.
Three-day sham (gluten free) dietary challenge
Eligibility Criteria
You may qualify if:
- Diagnosis of Celiac Disease by histology and serology
- For those with Type-1 Diabetes, at least one anti-islet antibody
- HLA-DQ2.5 genotype
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joslin Diabetes Centerlead
- ImmusanT, Inc.collaborator
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Gaglia, MD, MMSc
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Investigator
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 30, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 17, 2017
Record last verified: 2017-04