GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial)Oral Insulin Therapy for Prevention of Autoimmune Diabetes - GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial)

Technische Universität München, Represented by the school of medicine0 个研究点目标入组 1,040 人2018年2月27日

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注册库

who.int

开始日期

2018年2月27日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Technische Universität München, Represented by the school of medicine

•1\. Infant between the ages of 4 months and 7 months at the time of randomization.
•2\. A high genetic risk (\>10%) to develop beta\-cell autoantibodies by age 6 years:
•A) For infants without a first degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4\-DQ8 or DR4\-DQ8/DR4\-DQ8 genotype, and a genetic risk score that is \>14\.4\.
•B) For infants with a first degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503\.
•3\. Solid foods introduced into diet of infant
•4\. Written informed consent signed by the custodial parent(s).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1040
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range

•1\. Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.
•2\. Any condition that could be associated with poor compliance.
•3\. Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant’s safe participation in the study.
•4\. Diagnosis of diabetes at the time of recruitment.
•5\. Participation in another clinical trial.