Clinical trial NCT04984005: The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Official title: The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: children and adolescents
Obesity
metabolic syndrome
overweight
exercise
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 366
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from Baseline Obesity Indicators after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Body Fat Composition after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Blood Pressure after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Fasting Blood Glucose after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Total Serum Cholesterol after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Triglyceride after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Sexual Hormones after 3 months of exercise
timeFrame: Before and after three months of exercise training
Secondary outcomes:
measure: Changes from Baseline Exercise Performance after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Bone Mineral Density after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline C-reactive protein after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Serum Metabolomics after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Oral and Gut Microbiome after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Viromics after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Exome sequencing and genome sequencing
timeFrame: At baseline
measure: Changes from Baseline Proteomics after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Attention performance after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Sleep Quality after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Total Thyroid Hormone after 3 months of exercise
timeFrame: Before and after three months of exercise training
measure: Changes from Baseline Liver steatosis after 3 months of exercise
timeFrame: Before and after three months of exercise training
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: