A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel
研究概览
简要总结
A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 & 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA.
A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA.
Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-45 years
- •First-degree relatives of Type 1 Diabetes probands
- •Signing an informed consent
排除标准
- •Known diabetes of any kind (type 1, type 2, MODY)
- •Have a previous history of being treated with insulin or oral diabetes medications.
- •Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
结局指标
主要结局
The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel
时间窗: End of screening, 3 years after obtaining the first screening test
次要结局
- The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort(End of screening, 3 years after obtaining the first screening test)
- Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes(End of screening, 3 years after obtaining the first screening test)
- >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort(End of screening, 3 years after obtaining the first screening test)