Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 19
- 主要终点
- Change in mIAA Autoantibody Titer From Baseline
研究概览
简要总结
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
详细描述
A minimum of 40 eligible participants will be identified for study participation from the TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. All participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. Participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. During the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is relative of proband with type 1 diabetes
- •Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7 with an abnormal OGTT
- •Confirmed positive for insulin autoantibodies within previous six months
- •Confirmed positive for one or more other autoantibodies on two separate occasions within the past six months
排除标准
- •Diagnosed with type 1 diabetes
- •History of treatment with insulin or oral hypoglycemic agent
- •History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months
- •Ongoing use of medications known to influence glucose tolerance
- •Pregnant or intending to become pregnant while on study or lactating
研究组 & 干预措施
67.5 mg oral insulin crystals daily
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
干预措施: 67.5 mg oral insulin crystals daily (Drug)
500mg oral insulin crystals every other week
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
干预措施: 500mg oral insulin crystals every other week (Drug)
结局指标
主要结局
Change in mIAA Autoantibody Titer From Baseline
时间窗: 13 and 26 weeks after first dose versus baseline
Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response
Change in GAD65 Autoantibody Titer (DK Units/mL)
时间窗: 13 and 26 weeks after first dose versus baseline
Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
次要结局
未报告次要终点