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

P

Peking University

Status

Enrolling

Conditions

Obesity
Metabolic Syndrome

Treatments

Behavioral: Low intensity exercise training
Behavioral: Moderate intensity exercise training
Behavioral: Intermittent high intensity exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT04984005
M2021263

Details and patient eligibility

About

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.

Enrollment

366 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

366 participants in 3 patient groups

Low intensity exercise training group
Experimental group
Treatment:
Behavioral: Low intensity exercise training
Moderate intensity exercise training group
Experimental group
Treatment:
Behavioral: Moderate intensity exercise training
Intermittent high intensity exercise training group
Experimental group
Treatment:
Behavioral: Intermittent high intensity exercise training

Trial contacts and locations

1

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Central trial contact

Ming Xu, Prof.; Haiyi Yu, Dr.

Data sourced from clinicaltrials.gov

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