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

NCT ID: NCT04984005

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-11-30

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.

Conditions

Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low intensity exercise training group

Group Type: EXPERIMENTAL

Low intensity exercise training

Intervention Type: BEHAVIORAL

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

Moderate intensity exercise training group

Group Type: EXPERIMENTAL

Moderate intensity exercise training

Intervention Type: BEHAVIORAL

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

Intermittent high intensity exercise training group

Group Type: EXPERIMENTAL

Intermittent high intensity exercise training

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyi Yu, Dr.

Role: CONTACT

yuhaiyi@bjmu.edu.cn

0086013466615475

Ming Xu, Prof.

Role: CONTACT

xuminghi@bjmu.edu.cn

0086013683388938

Facility Contacts

Haiyi Yu, Dr

Role: primary

yuhaiyi@bjmu.edu.cn

008613466615475

Ming Xu, Prof

Role: backup

xuminghi@bjmu.edu.cn

008613683388938

Other Identifiers

M2021263

Identifier Type: -

Identifier Source: org_study_id