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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04984005

Collaborator

(none)

366

Enrollment

Location

Arms

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Metabolic Syndrome	Behavioral: Low intensity exercise training Behavioral: Moderate intensity exercise training Behavioral: Intermittent high intensity exercise training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Obesity indicators [Exercise training for 12 weeks]
BMI in kg/m^2

Secondary Outcome Measures

Index of metabolic syndrome: waist height ratio [Exercise training for 12 weeks]
WHtR in cm/m
Index of metabolic syndrome: HDL [Exercise training for 12 weeks]
HDL in mg/dL
Index of metabolic syndrome: TG [Exercise training for 12 weeks]
TG in in mg/dL
Index of metabolic syndrome: blood glucose [Exercise training for 12 weeks]
fasting blood glucose in blood mg/dL
Index of metabolic syndrome: blood pressure [Exercise training for 12 weeks]
blood pressure in mmHg
Multi-omics [Exercise training for 12 weeks]
Metabolomics, gut microbiome, genetics, proteomics.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.