Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

This study is currently recruiting participants.
Verified March 2014 by Joslin Diabetes Center
Sponsor:
Collaborator:
ImmusanT, Inc.
Information provided by (Responsible Party):
Jason Gaglia, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01932476
First received: August 14, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention
Type 1 Diabetes
Celiac Disease
Dietary Supplement: Gluten Challenge
Dietary Supplement: Sham Challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Change in Markers of Autoimmunity [ Time Frame: Baseline and day 3 post challenge ] [ Designated as safety issue: No ]
    Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.


Secondary Outcome Measures:
  • Gastrointestinal Symptoms [ Time Frame: Baseline and 6 days ] [ Designated as safety issue: Yes ]
    Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.


Estimated Enrollment: 52
Study Start Date: August 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932476

Contacts
Contact: Sarah Szubowicz, MPH 617-309-4493 sarah.szubowicz@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Baidal, MD    888-813-8669    david.baidal@joslin.harvard.edu   
Principal Investigator: Jason Gaglia, MD, MMSc         
Sponsors and Collaborators
Joslin Diabetes Center
ImmusanT, Inc.
Investigators
Principal Investigator: Jason Gaglia, MD, MMSc Joslin Diabetes Center
  More Information

No publications provided

Responsible Party: Jason Gaglia, Assistant Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01932476     History of Changes
Other Study ID Numbers: GC001
Study First Received: August 14, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014