Prevent CardioKids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Vascular function measured by peripheral arterial tonometry (EndoPAT)
研究概览
简要总结
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.
详细描述
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.The primary endpoint is to examine the difference in micro- and macro-vasculature characteristics in children with different weight classifications (lean; overweight; obese; extreme obese; morbid obese). Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory and oral glucose tolerance profiles between different age groups, between lean and overweight/obese children and in relation with the measured micro- and macro-vasculature characteristics
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in the COACH program
- •Aged between 6 and 18 years (at time of inclusion)
- •Overweight or obesity according to IOTF criteria
- •In order to be eligible to participate in the control group, a subject must meet all of the following criteria:
- •Aged between 6 and 18 years
- •Normal weight according to the IOTF criteria
- •Undergo surgery for elective reasons
排除标准
- •Retarded children
- •Children suffering from:
- •Inflammatory diseases: auto-immune diseases, inflammatory bowel diseases, hepatitis, dermatitis, nephritis, pancreatitis, gastro-enteritis, vasculitis, salpingitis, arthritis, osteomyelitis, myositis, ear-nose-throat infections
- •Allergic diseases: asthma, eczema, hay fever, food allergies
- •Oncologic diseases
- •Cystic fibrosis
- •Type 1 diabetes mellitus
- •Congenital metabolic diseases
- •Malnourished children
结局指标
主要结局
Vascular function measured by peripheral arterial tonometry (EndoPAT)
时间窗: 1 year
The primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups.
次要结局
- Differences in characteristics of the microcirculation as measured via fundus photography(1 year)
- Differences in characteristics of microcirculation measured via lipoprotein profiles(1 year)
- Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles(1 year)