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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04984005
Enrollment
366
Registered
2021-07-30
Start date
2022-03-01
Completion date
2025-11-30
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Metabolic Syndrome

Keywords

children and adolescents, Obesity, metabolic syndrome, overweight, exercise

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.

Interventions

The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a low-intensity exercise training.

The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a moderate-intensity exercise training.

BEHAVIORALIntermittent high intensity exercise training

The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a high-intensity exercise training.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes from Baseline Obesity Indicators after 3 months of exerciseBefore and after three months of exercise trainingBMI in kg/m\^2
Changes from Baseline Body Fat Composition after 3 months of exerciseBefore and after three months of exercise trainingBody fat composition (%)
Changes from Baseline Peak Metabolic Equivalent after 3 months of exerciseBefore and after three months of exercise trainingPeak Metabolic Equivalent in MET
Changes from Baseline Blood Pressure after 3 months of exerciseBefore and after three months of exercise trainingBlood pressure in mmHg
Changes from Baseline Fasting Blood Glucose after 3 months of exerciseBefore and after three months of exercise trainingFasting Blood Glucose in mmol/L
Changes from Baseline Total Serum Cholesterol after 3 months of exerciseBefore and after three months of exercise trainingTotal Serum Cholesterol in mmol/L
Changes from Baseline Triglyceride after 3 months of exerciseBefore and after three months of exercise trainingTriglyceride in mmol/L
Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exerciseBefore and after three months of exercise trainingSerum High-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exerciseBefore and after three months of exercise trainingSerum Low-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Sexual Hormones after 3 months of exerciseBefore and after three months of exercise trainingDetection of hormone indicators related to growth and development

Secondary

MeasureTime frameDescription
Changes from Baseline Proteomics after 3 months of exerciseBefore and after three months of exercise trainingproteomics
Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exerciseBefore and after three months of exercise trainingCollect exhaled gas and use mass spectrometry for small molecule detection
Changes from Baseline Liver steatosis after 3 months of exerciseBefore and after three months of exercise trainingAbdominal ultrasound evaluation of the presence of hepatic steatosis
Changes from Baseline Sleep Quality after 3 months of exerciseBefore and after three months of exercise trainingWearing a heart rate monitoring watch to collect data
Changes from Baseline Total Thyroid Hormone after 3 months of exerciseBefore and after three months of exercise trainingTotal Thyroid Hormone in nmol/L
Changes from Baseline Attention performance after 3 months of exerciseBefore and after three months of exercise trainingAttention Survey Questionnaire
Changes from Baseline Exercise Performance after 3 months of exerciseBefore and after three months of exercise trainingVO2max/Kg in mL/min/Kg
Changes from Baseline Hepatic Hemodynamic Index after 3 months of exerciseBefore and after three months of exercise trainingwall shear stress in proper hepatic artery,Pa
Changes from Baseline Bone Mineral Density after 3 months of exerciseBefore and after three months of exercise trainingUsing ultrasound bone density instruments for detection
Changes from Baseline C-reactive protein after 3 months of exerciseBefore and after three months of exercise trainingInflammatory Biomarker C-reactive protein in mg/L
Changes from Baseline Oxidative Stress Biomarkers after 3 months of exerciseBefore and after three months of exercise trainingOxidative Stress Biomarker MDA in nmol/mL
Changes from Baseline Serum Metabolomics after 3 months of exerciseBefore and after three months of exercise trainingMetabolomics
Changes from Baseline Oral and Gut Microbiome after 3 months of exerciseBefore and after three months of exercise trainingoral and gut microbiome
Changes from Baseline Viromics after 3 months of exerciseBefore and after three months of exercise trainingviromics
Exome sequencing and genome sequencingAt baselinegenetics

Countries

China

Contacts

Primary ContactHaiyi Yu, Dr.
yuhaiyi@bjmu.edu.cn0086013466615475
Backup ContactMing Xu, Prof.
xuminghi@bjmu.edu.cn0086013683388938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026