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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Low intensity exercise training; Behavioral: Moderate intensity exercise training; Behavioral: Intermittent high intensity exercise training

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyi Yu, Dr.; Phone Number: 0086013466615475; Email: yuhaiyi@bjmu.edu.cn
• Study Contact Backup: Name: Ming Xu, Prof.; Phone Number: 0086013683388938; Email: xuminghi@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Haiyi Yu, Dr; Phone Number: 008613466615475; Email: yuhaiyi@bjmu.edu.cn
      • Contact: Ming Xu, Prof; Phone Number: 008613683388938; Email: xuminghi@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; exercise; overweight; metabolic syndrome; children and adolescents
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Metabolic Diseases
• Other Study ID Numbers: M2021263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No