NCT04789993Unknown不适用
Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Type of additional autoimmune diseases at type 1 diabetes diagnosis
研究概览
简要总结
This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes diagnosed with the following criteria: (i) Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dl), or (ii) fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl) ; and (iii) presence of diabetes associated autoantibodies : ICA, GAD, IA2, IAA and/or ZnT8
- •age < 18 years old at type 1 diabetes diagnostic
- •type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01
排除标准
- •type 1 diabetes diagnostic not certain
结局指标
主要结局
Type of additional autoimmune diseases at type 1 diabetes diagnosis
时间窗: up to 3 weeks after type 1 diabetes diagnosis
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Number of additional autoimmune diseases at type 1 diabetes diagnosis
时间窗: up to 3 weeks after type 1 diabetes diagnosis
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
次要结局
- Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5(From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes(during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto(From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic(up to 3 weeks after type 1 diabetes diagnosis)
- Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease(From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction(Up to 3 weeks after type 1 diabetes diagnosis)
- Characteristics of patients, if additional autoimmune disease is present or absent(up to 3 weeks after type 1 diabetes diagnosis)
- Occurence or non-occurence of at least one additional autoimmune diseases during follow-up(From type 1 diabetes diagnostic to last news date, an average of 3 years)
- Occurence or non-occurence of each type of additional autoimmune disease during follow-up(From type 1 diabetes diagnostic to last news date, an average of 3 years)
- Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes(Up to 3 weeks after type 1 diabetes diagnosis)
- Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic(up to 3 weeks after type 1 diabetes diagnosis)
- Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto(From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic(up to 3 weeks after type 1 diabetes diagnosis)
- If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease(From type 1 diabetes diagnosis to last news date, from 1 to 6 years)
- Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment(Up to 3 weeks after type 1 diabetes diagnosis)
研究者
LEGAGNEUR Carole
MD
Central Hospital, Nancy, France
研究点 (1)
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