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临床试验/NCT03269084
NCT03269084招募中不适用

Type 1 Diabetes Prediction and Prevention (DIPP) Study

Riitta Veijola3 个研究点 分布在 1 个国家目标入组 17,000 人开始时间: 1994年11月7日最近更新:
适应症

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

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

发起方
Riitta Veijola
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Riitta Veijola

Professor of Pediatrics

University of Oulu

研究点 (3)

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