The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases

Study Overview
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Brief Summary
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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.

Official Title
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The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases

Conditions
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Low intensity exercise training
* Behavioral: Moderate intensity exercise training
* Behavioral: Intermittent high intensity exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of overweight or obesity or metabolic syndrome; Good academic performance in school; Willing to sign informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low intensity exercise training group<br> | Behavioral: Low intensity exercise training<br>* The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a low-intensity exercise training.<br>|
| Experimental: Moderate intensity exercise training group<br> | Behavioral: Moderate intensity exercise training<br>* The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a moderate-intensity exercise training.<br>|
| Experimental: Intermittent high intensity exercise training group<br> | Behavioral: Intermittent high intensity exercise training<br>* The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a high-intensity exercise training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Obesity Indicators after 3 months of exercise | BMI in kg/m^2 | Before and after three months of exercise training | 
| Changes from Baseline Body Fat Composition after 3 months of exercise | Body fat composition (%) | Before and after three months of exercise training | 
| Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise | Peak Metabolic Equivalent in MET | Before and after three months of exercise training | 
| Changes from Baseline Blood Pressure after 3 months of exercise | Blood pressure in mmHg | Before and after three months of exercise training | 
| Changes from Baseline Fasting Blood Glucose after 3 months of exercise | Fasting Blood Glucose in mmol/L | Before and after three months of exercise training | 
| Changes from Baseline Total Serum Cholesterol after 3 months of exercise | Total Serum Cholesterol in mmol/L | Before and after three months of exercise training | 
| Changes from Baseline Triglyceride after 3 months of exercise | Triglyceride in mmol/L | Before and after three months of exercise training | 
| Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise | Serum High-density Lipoprotein Cholesterol in mmol/L | Before and after three months of exercise training | 
| Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise | Serum Low-density Lipoprotein Cholesterol in mmol/L | Before and after three months of exercise training | 
| Changes from Baseline Sexual Hormones after 3 months of exercise | Detection of hormone indicators related to growth and development | Before and after three months of exercise training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Exercise Performance after 3 months of exercise | VO2max/Kg in mL/min/Kg | Before and after three months of exercise training | 
| Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise | wall shear stress in proper hepatic artery，Pa | Before and after three months of exercise training | 
| Changes from Baseline Bone Mineral Density after 3 months of exercise | Using ultrasound bone density instruments for detection | Before and after three months of exercise training | 
| Changes from Baseline C-reactive protein after 3 months of exercise | Inflammatory Biomarker C-reactive protein in mg/L | Before and after three months of exercise training | 
| Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise | Oxidative Stress Biomarker MDA in nmol/mL | Before and after three months of exercise training | 
| Changes from Baseline Serum Metabolomics after 3 months of exercise | Metabolomics | Before and after three months of exercise training | 
| Changes from Baseline Oral and Gut Microbiome after 3 months of exercise | oral and gut microbiome | Before and after three months of exercise training | 
| Changes from Baseline Viromics after 3 months of exercise | viromics | Before and after three months of exercise training | 
| Exome sequencing and genome sequencing | genetics | At baseline | 
| Changes from Baseline Proteomics after 3 months of exercise | proteomics | Before and after three months of exercise training | 
| Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise | Collect exhaled gas and use mass spectrometry for small molecule detection | Before and after three months of exercise training | 
| Changes from Baseline Attention performance after 3 months of exercise | Attention Survey Questionnaire | Before and after three months of exercise training | 
| Changes from Baseline Sleep Quality after 3 months of exercise | Wearing a heart rate monitoring watch to collect data | Before and after three months of exercise training | 
| Changes from Baseline Total Thyroid Hormone after 3 months of exercise | Total Thyroid Hormone in nmol/L | Before and after three months of exercise training | 
| Changes from Baseline Liver steatosis after 3 months of exercise | Abdominal ultrasound evaluation of the presence of hepatic steatosis | Before and after three months of exercise training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, metabolic syndrome, overweight, exercise, children and adolescents