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

NCT04984005 | Unknown DMC

• 1 other identifier: M2021263
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (15)

• Changes from Baseline Exercise Performance after 3 months of exercise

  Before and after three months of exercise training

• Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise

  Before and after three months of exercise training

• Changes from Baseline Bone Mineral Density after 3 months of exercise

  Before and after three months of exercise training

• Changes from Baseline C-reactive protein after 3 months of exercise

  Before and after three months of exercise training

• Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise

  Before and after three months of exercise training

Study Arms (3)

Low intensity exercise training group

EXPERIMENTAL

Behavioral: Low intensity exercise training

Moderate intensity exercise training group

EXPERIMENTAL

Behavioral: Moderate intensity exercise training

Intermittent high intensity exercise training group

EXPERIMENTAL

Behavioral: Intermittent high intensity exercise training

Interventions

Low intensity exercise training 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.

Low intensity exercise training group

Moderate intensity exercise training 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.

Moderate intensity exercise training group

Intermittent high intensity exercise training 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.

Intermittent high intensity exercise training group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of overweight or obesity or metabolic syndrome;
• Good academic performance in school;
• Willing to sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Central Study Contacts

Haiyi Yu, Dr.

CONTACT

0086013466615475; yuhaiyi@bjmu.edu.cn

Ming Xu, Prof.

CONTACT

0086013683388938; xuminghi@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2025
• Last Updated: June 23, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)