The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Changes from Baseline Obesity Indicators after 3 months of exercise
研究概览
简要总结
In order to obtain suitable exercise intervention model for children and adolescents with obese or metabolic syndrome in China, we conduct a RCT to examine the effects of different intensity exercise intervention on weight, and other cardiometabolic risk factors among children and adolescents, we also test the effects of exercise interventions on multi-omics such as metabolomics, gut microbiome, genetics, and explore the potential mechanisms by which exercise interventions modulate cardiometabolic risk. This is a randomized controlled study. Children and adolescents with obesity or metabolic syndrome were randomly divided into three groups, including low intensity exercise training group, moderate and intermittent high intensity exercise training group. The investigators will obtain organ hydrodynamics indexes by abdominal ultrasound and computational fluid dynamics technology, and obtain the metabolic regulation mechanism of the body in response to exercise through the detection of metabolism related small molecules in blood and urine and the analysis of intestinal flora, so as to explore the potential value and mechanism of different exercise modes in the treatment of obesity and metabolic syndrome. At the same time, the behavior and self-consciousness of children and adolescents will be investigated to obtain the suitable exercise intervention model for Chinese children and adolescents with obesity and metabolic syndrome. In conclusion, this study aims to demonstrate which exercise mode can alleviate obesity or reverse metabolic diseases, analyze which factors can sense exercise, and explore the potential mechanisms through mutil-omic approach, so as to improve metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of overweight or obesity or metabolic syndrome;
- •Good academic performance in school;
- •Willing to sign informed consent.
排除标准
- •Clinical diagnosis of Cushing syndrome;
- •Pathological obesity such as Prader-Willi syndrome and obesity caused by drug factors；
- •Participated in other intervention studies within the previous three months;
- •participant or their guardian has obvious intellectual or mental abnormalities.
结局指标
主要结局
Changes from Baseline Obesity Indicators after 3 months of exercise
时间窗: Before and after three months of exercise training
BMI in kg/m\^2
Changes from Baseline Body Fat Composition after 3 months of exercise
时间窗: Before and after three months of exercise training
Body fat composition (%)
Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise
时间窗: Before and after three months of exercise training
Peak Metabolic Equivalent in MET
Changes from Baseline Blood Pressure after 3 months of exercise
时间窗: Before and after three months of exercise training
Blood pressure in mmHg
Changes from Baseline Sexual Hormones after 3 months of exercise
时间窗: Before and after three months of exercise training
Detection of hormone indicators related to growth and development
Changes from Baseline Triglyceride after 3 months of exercise
时间窗: Before and after three months of exercise training
Triglyceride in mmol/L
Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise
时间窗: Before and after three months of exercise training
Serum High-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise
时间窗: Before and after three months of exercise training
Serum Low-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Fasting Blood Glucose after 3 months of exercise
时间窗: Before and after three months of exercise training
Fasting Blood Glucose in mmol/L
Changes from Baseline Total Serum Cholesterol after 3 months of exercise
时间窗: Before and after three months of exercise training
Total Serum Cholesterol in mmol/L
次要结局
- Changes from Baseline Exercise Performance after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Bone Mineral Density after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline C-reactive protein after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Serum Metabolomics after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Oral and Gut Microbiome after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Viromics after 3 months of exercise(Before and after three months of exercise training)
- Exome sequencing and genome sequencing(At baseline)
- Changes from Baseline Proteomics after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Attention performance after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Sleep Quality after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Total Thyroid Hormone after 3 months of exercise(Before and after three months of exercise training)
- Changes from Baseline Liver steatosis after 3 months of exercise(Before and after three months of exercise training)