跳至主要内容
临床试验/NCT05788341
NCT05788341招募中不适用

The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Positive Islet Autoantibodies

研究概览

简要总结

We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).

Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

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

入选标准

  • First degree family member (sibling or parent) of a known T1D patient
  • Age 2-45 years
  • Signing an informed consent

排除标准

  • Known diabetes of any kind (type 2, MODY)
  • Have a previous history of being treated with insulin or oral diabetes medications.
  • Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

结局指标

主要结局

Positive Islet Autoantibodies

时间窗: Screening visit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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