Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
NCT ID: NCT01932476
Last Updated: 2017-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2013-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Celiac Disease Alone Gluten Challenge
Gluten Challenge
Three-day gluten containing dietary challenge.
Celiac Disease Alone Sham Challenge
Sham Challenge
Three-day sham (gluten free) dietary challenge
Celiac Disease and T1D Gluten Challenge
Gluten Challenge
Three-day gluten containing dietary challenge.
Celiac Disease and T1D Sham Challenge
Sham Challenge
Three-day sham (gluten free) dietary challenge
Interventions
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Gluten Challenge
Three-day gluten containing dietary challenge.
Sham Challenge
Three-day sham (gluten free) dietary challenge
Eligibility Criteria
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Inclusion Criteria
* For those with Type-1 Diabetes, at least one anti-islet antibody
* HLA-DQ2.5 genotype
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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ImmusanT, Inc.
INDUSTRY
Joslin Diabetes Center
OTHER
Responsible Party
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Jason Gaglia
Assistant Investigator
Principal Investigators
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Jason Gaglia, MD, MMSc
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Locations
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Joslin Diabetes Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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GC001
Identifier Type: -
Identifier Source: org_study_id
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