Type 1 Diabetes Prediction and Prevention (DIPP) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17,000
- 试验地点
- 3
- 主要终点
- Positivity for at least one islet autoantibody
研究概览
简要总结
The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.
详细描述
Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland
排除标准
- •Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
结局指标
主要结局
Positivity for at least one islet autoantibody
时间窗: December 31, 2021
ICA, IAA, GADA, IA-2A or ZnT8A
Clinical diagnosis of type 1 diabetes
时间窗: December 31, 2021
Hyperglycemia as defined by WHO
次要结局
未报告次要终点
研究者
Riitta Veijola
Professor of Pediatrics
University of Oulu
