Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
研究概览
简要总结
For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. This study intends to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types.
详细描述
Atherosclerotic cardiovascular disease (ASCVD) is the main cause of death in patients with diabetes. Currently recognized ASCVD risk assessment models are limited to adults with diabetes, but for children and adolescents with diabetes, the pathological process of ASCVD can exist in early childhood and progress rapidly to subclinical ASCVD.
To sum up, this study intends to evaluate the high risk rate of ASCVD calculated by the traditional QRISK3 model and its correlation with the occurrence of subclinical ASCVD events through long-term follow-up of the natural history of diabetes onset in children and adolescents, and to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types. This study aims to help block the pathological process of ASCVD in early duration, thereby reducing the occurrence of ASCVD in childhood and teen-age onset diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes or type 2 diabetes
- •Age of onset: <18y
- •Enrollment age: ≥18y
- •Gender: male or female
- •Diabetes duration ≥ 5 years
排除标准
- •Specific types of diabetes
- •Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes
- •Pregnancy or lactation
- •Received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously
- •Onset of acute complications of diabetes in the past 3 months
- •Major trauma and surgery history in the past 3 months
结局指标
主要结局
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
时间窗: 5 years
Risk value calculated by QRISK3 model \>10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)
次要结局
- Occurrence of subclinical ASCVD(carotid intima-media thickness)(5 years)
- Occurrence of subclinical ASCVD(coronary artery calcium)(5 years)
- Occurrence of subclinical ASCVD(carotid plaque)(5 years)
- Occurrence of subclinical ASCVD(pulse wave velocity)(5 years)
研究者
Weiqiong Gu
Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
Shanghai Jiao Tong University School of Medicine