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Completed

NCT Number: NCT01932476

Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Celiac Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten Challenge

Dietary Supplement

Three-day gluten containing dietary challenge.

Sham Challenge

Dietary Supplement

Three-day sham (gluten free) dietary challenge

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • ImmusanT, Inc.

Registry information

Official study title

Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2013
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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