Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Type 1 Diabetes, Celiac Disease

In brief

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.

Key facts

Study ID

NCT01932476

Run by

Joslin Diabetes Center

People needed

7

Starts

2013-08-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Celiac Disease by histology and serology
• For those with Type-1 Diabetes, at least one anti-islet antibody
• HLA-DQ2.5 genotype

You may not qualify if…

• 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

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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