Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months
研究概览
简要总结
The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.
详细描述
The favorable responses of combined treatment strategies, consisting of exercise training and proper diet change, for childhood and adolescent obesity on vascular health are poorly understood. The overall objective of this research project is to investigate the underlying pathophysiological mechanisms that mediate these beneficial effects.
Particularly, the following aims are set forth:
- To establish the effect of a combined lifestyle intervention, i.e. an individualized exercise training and caloric restriction program, on vascular function (primary endpoint) and structure in a substantial population of obese adolescents.
- To characterize causal pathways between obesity and endothelial dysfunction with focus on classical risk factors, oxidative and inflammatory stress, metabolic adaptations, bone marrow derived progenitor cells, and blood microparticles.
This research knowledge will be instrumental for risk stratification and clinical management aimed to improve endothelial function by limiting damage and reinforcing regenerative mechanisms in obese adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with severe obesity
- •Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
- •Older than 16 yrs: BMI ≥35 kg/m²
排除标准
- •Acute or chronic inflammatory process, use of non-steroidal anti- inflammatory drugs or immunosuppressive drugs. (including inhalation corticosteroids).
- •Structural heart disease or other cardiac diseases.
- •Active malignant hematological disease
结局指标
主要结局
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months
时间窗: Baseline - 5 months - 10 months
Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function
次要结局
- Change From Baseline in Exercise Capacity at 5 and 10 Months(Baseline - 5 months - 10 months)
- Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months(Baseline - 5 months - 10 months)
研究者
Luc Bruyndonckx
Principal Investigator
University Hospital, Antwerp