Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932476
• Other study ID #: GC001
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: April 13, 2017
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Celiac Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Dietary Supplement:
• Gluten Challenge
Three-day gluten containing dietary challenge.
• Sham Challenge
Three-day sham (gluten free) dietary challenge

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	ImmusanT, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Markers of Autoimmunity	Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.	Baseline and day 3 post challenge
Secondary	Gastrointestinal Symptoms	Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.	Baseline and 6 days