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Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

This study has been completed.
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: April 13, 2017
Last verified: April 2017
  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: 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

Resource links provided by NLM:


Further study details as provided by Jason Gaglia, Joslin Diabetes Center:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 7
Actual Study Start Date: August 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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   (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
  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

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
  More Information

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: April 13, 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

ClinicalTrials.gov processed this record on June 28, 2017