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Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

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ClinicalTrials.gov Identifier: NCT01932476
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
ImmusanT, Inc.
Information provided by (Responsible Party):
Jason Gaglia, Joslin Diabetes Center

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Celiac Disease Dietary Supplement: Gluten Challenge Dietary Supplement: Sham Challenge Not Applicable

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932476


Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
ImmusanT, Inc.
Investigators
Principal Investigator: Jason Gaglia, MD, MMSc Joslin Diabetes Center

Responsible Party: Jason Gaglia, Assistant Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01932476     History of Changes
Other Study ID Numbers: GC001
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Celiac Disease
Autoimmune Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases