Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014