Gluten and Amylase Trypsin Inhibitors (ATI) as Nutritional Contributors to Type 1 Diabetes Susceptibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in the plasma-induced transcriptional assay
研究概览
简要总结
Siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. Through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. The investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 2-23 years of age
- •Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
- •Treatment naïve of any immunomodulatory agent
排除标准
- •Abnormal HbA1c, defined as ≥ 6%
- •Previous or current use of a gluten-free diet
- •Current diagnosis of celiac disease
- •An elevated tissue transglutaminase IgA level (> 10 units/mL)
- •Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
- •Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
- •Use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months)
- •Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
- •Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
结局指标
主要结局
Change in the plasma-induced transcriptional assay
时间窗: 2 years (study duration)
Investigators will measure the participants overall immune inflammation and regulation by a plasma-induced transcriptional bioassay. The change in this bioassay will be determined for each subject and the entire group both before and after the dietary intervention. This bioassay informs the investigators of which genes may be positively or negatively impacted by this dietary change and whether the removal of gluten and amylase trypsin inhibitors (ATI) affects a participant's immune state.
次要结局
- Leukocyte analyses(2 years (study duration))
- Stool microbial composition(2 years (study duration))
- Plasma microbial antigen detection(2 years (study duration))
研究者
Susanne Cabrera
Principal Investigator
Medical College of Wisconsin