Genetics Of Autoimmunity In Type I Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Autoantibody Measurement
研究概览
简要总结
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.
详细描述
The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.
Participants will have height and weight measured, complete a social & medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Families):
- •Families where at least one first-degree family member has type 1 diabetes
- •The diabetic proband in the family was diagnosed before the age of 39
- •Family members must be at least 2 years old to participate
排除标准
- •(Families):
- •Families with no history of type 1 diabetes
- •Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
- •Inclusion Criteria (Controls):
- •No family history of type 1 diabetes or other autoimmune conditions
- •Age 2 or older
- •Exclusion Criteria (Controls):
- •Personal or family history of autoimmune disease
结局指标
主要结局
Autoantibody Measurement
时间窗: Up to 10 years
Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)
Onset of Type 1 diabetes
时间窗: Up to 10 years
The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.
次要结局
未报告次要终点
研究者
Martin Hessner
Professor
Medical College of Wisconsin