Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Markers of Autoimmunity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Celiac Disease by histology and serology
- •For those with Type-1 Diabetes, at least one anti-islet antibody
- •HLA-DQ2.5 genotype
排除标准
- •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
研究组 & 干预措施
Celiac Disease and T1D Sham Challenge
干预措施: Sham Challenge (Dietary Supplement)
Celiac Disease Alone Gluten Challenge
干预措施: Gluten Challenge (Dietary Supplement)
Celiac Disease Alone Sham Challenge
干预措施: Sham Challenge (Dietary Supplement)
Celiac Disease and T1D Gluten Challenge
干预措施: Gluten Challenge (Dietary Supplement)
结局指标
主要结局
Change in Markers of Autoimmunity
时间窗: Baseline and day 3 post challenge
Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.
次要结局
- Gastrointestinal Symptoms(Baseline and 6 days)
研究者
Jason Gaglia
Assistant Investigator
Joslin Diabetes Center