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AzTrials

ObesityNCT04984005

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

A study testing Low intensity exercise training, Moderate intensity exercise training and Intermittent high intensity exercise training in people with Obesity and Metabolic Syndrome, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 16 years
Conditions the study is for
Obesity, Metabolic Syndrome
What is being tested?
Low intensity exercise training, Moderate intensity exercise training and Intermittent high intensity exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
1 siteChina
Study dates
1 Mar 2022to 14 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

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.

Being tested
Low intensity exercise training, Moderate intensity exercise training, Intermittent high intensity exercise training
Keywords
children and adolescents, Obesity, metabolic syndrome, overweight, exercise
Medical subject headings
Obesity, Metabolic Syndrome, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low intensity exercise trainingBehavioural

    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 trainingBehavioural

    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 trainingBehavioural

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

Study groups in NCT04984005
Study groupRoleWhat they receive
Low intensity exercise training groupExperimentalNot described
Receives: Behavioral: Low intensity exercise training
Moderate intensity exercise training groupExperimentalNot described
Receives: Behavioral: Moderate intensity exercise training
Intermittent high intensity exercise training groupExperimentalNot described
Receives: Behavioral: Intermittent high intensity exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from Baseline BMI z-score after 3 months of exercise

    BMI-for-age z-score calculated using the WHO 2007 growth reference for children and adolescents aged 5-19 years. BMI z-score is the primary outcome specified in the statistical analysis plan for the 12-week intervention report; the other registered outcomes are secondary or are reported separately.

    Measured: Before and after three months (12 weeks) of exercise training

  2. Changes from Baseline Obesity Indicators after 3 months of exercise

    BMI in kg/m^2

    Measured: Before and after three months of exercise training

  3. Changes from Baseline Body Fat Composition after 3 months of exercise

    Body fat composition (%)

    Measured: Before and after three months of exercise training

  4. Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise

    Peak Metabolic Equivalent in MET

    Measured: Before and after three months of exercise training

  5. Changes from Baseline Blood Pressure after 3 months of exercise

    Blood pressure in mmHg

    Measured: Before and after three months of exercise training

  6. Changes from Baseline Fasting Blood Glucose after 3 months of exercise

    Fasting Blood Glucose in mmol/L

    Measured: Before and after three months of exercise training

  7. Changes from Baseline Total Serum Cholesterol after 3 months of exercise

    Total Serum Cholesterol in mmol/L

    Measured: Before and after three months of exercise training

  8. Changes from Baseline Triglyceride after 3 months of exercise

    Triglyceride in mmol/L

    Measured: Before and after three months of exercise training

  9. Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise

    Serum High-density Lipoprotein Cholesterol in mmol/L

    Measured: Before and after three months of exercise training

  10. Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise

    Serum Low-density Lipoprotein Cholesterol in mmol/L

    Measured: Before and after three months of exercise training

  11. Changes from Baseline Sexual Hormones after 3 months of exercise

    Detection of hormone indicators related to growth and development

    Measured: Before and after three months of exercise training

Secondary outcomes (15)

  1. Changes from Baseline Exercise Performance after 3 months of exercise

    VO2max/Kg in mL/min/Kg

    Measured: Before and after three months of exercise training

  2. Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise

    wall shear stress in proper hepatic artery，Pa

    Measured: Before and after three months of exercise training

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

    Using ultrasound bone density instruments for detection

    Measured: Before and after three months of exercise training

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

    Inflammatory Biomarker C-reactive protein in mg/L

    Measured: Before and after three months of exercise training

  5. Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise

    Oxidative Stress Biomarker MDA in nmol/mL

    Measured: Before and after three months of exercise training

  6. Changes from Baseline Serum Metabolomics after 3 months of exercise

    Metabolomics

    Measured: Before and after three months of exercise training

  7. Changes from Baseline Oral and Gut Microbiome after 3 months of exercise

    oral and gut microbiome

    Measured: Before and after three months of exercise training

  8. Changes from Baseline Viromics after 3 months of exercise

    viromics

    Measured: Before and after three months of exercise training

  9. Exome sequencing and genome sequencing

    genetics

    Measured: At baseline

  10. Changes from Baseline Proteomics after 3 months of exercise

    proteomics

    Measured: Before and after three months of exercise training

  11. Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise

    Collect exhaled gas and use mass spectrometry for small molecule detection

    Measured: Before and after three months of exercise training

  12. Changes from Baseline Attention performance after 3 months of exercise

    Attention Survey Questionnaire

    Measured: Before and after three months of exercise training

  13. Changes from Baseline Sleep Quality after 3 months of exercise

    Wearing a heart rate monitoring watch to collect data

    Measured: Before and after three months of exercise training

  14. Changes from Baseline Total Thyroid Hormone after 3 months of exercise

    Total Thyroid Hormone in nmol/L

    Measured: Before and after three months of exercise training

  15. Changes from Baseline Liver steatosis after 3 months of exercise

    Abdominal ultrasound evaluation of the presence of hepatic steatosis

    Measured: Before and after three months of exercise training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start1 Mar 2022
  3. Primary completion14 Jun 2023
  4. Study completion14 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984005
Sponsor's protocol ID
M2021263
Status last verified
Mar 2025
First submitted
21 Jul 2021
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Low intensity exercise training, Moderate intensity exercise training and Intermittent high intensity exercise training in people with Obesity and Metabolic Syndrome, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from Baseline BMI z-score after 3 months of exercise (time frame: Before and after three months (12 weeks) of exercise training). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04984005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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