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

June 20, 2023 updated by: Peking University Third Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline Obesity Indicators after 3 months of exercise
Time Frame: Before and after three months of exercise training
BMI in kg/m^2
Before and after three months of exercise training
Changes from Baseline Body Fat Composition after 3 months of exercise
Time Frame: Before and after three months of exercise training
Body fat composition (%)
Before and after three months of exercise training
Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise
Time Frame: Before and after three months of exercise training
Peak Metabolic Equivalent in MET
Before and after three months of exercise training
Changes from Baseline Blood Pressure after 3 months of exercise
Time Frame: Before and after three months of exercise training
Blood pressure in mmHg
Before and after three months of exercise training
Changes from Baseline Fasting Blood Glucose after 3 months of exercise
Time Frame: Before and after three months of exercise training
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
Time Frame: Before and after three months of exercise training
Total Serum Cholesterol in mmol/L
Before and after three months of exercise training
Changes from Baseline Triglyceride after 3 months of exercise
Time Frame: Before and after three months of exercise training
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
Time Frame: Before and after three months of exercise training
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
Time Frame: Before and after three months of exercise training
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
Time Frame: Before and after three months of exercise training
Detection of hormone indicators related to growth and development
Before and after three months of exercise training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline Exercise Performance after 3 months of exercise
Time Frame: Before and after three months of exercise training
VO2max/Kg in mL/min/Kg
Before and after three months of exercise training
Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise
Time Frame: Before and after three months of exercise training
wall shear stress in proper hepatic artery，Pa
Before and after three months of exercise training
Changes from Baseline Bone Mineral Density after 3 months of exercise
Time Frame: Before and after three months of exercise training
Using ultrasound bone density instruments for detection
Before and after three months of exercise training
Changes from Baseline C-reactive protein after 3 months of exercise
Time Frame: Before and after three months of exercise training
Inflammatory Biomarker C-reactive protein in mg/L
Before and after three months of exercise training
Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise
Time Frame: Before and after three months of exercise training
Oxidative Stress Biomarker MDA in nmol/mL
Before and after three months of exercise training
Changes from Baseline Serum Metabolomics after 3 months of exercise
Time Frame: Before and after three months of exercise training
Metabolomics
Before and after three months of exercise training
Changes from Baseline Oral and Gut Microbiome after 3 months of exercise
Time Frame: Before and after three months of exercise training
oral and gut microbiome
Before and after three months of exercise training
Changes from Baseline Viromics after 3 months of exercise
Time Frame: Before and after three months of exercise training
viromics
Before and after three months of exercise training
Exome sequencing and genome sequencing
Time Frame: At baseline
genetics
At baseline
Changes from Baseline Proteomics after 3 months of exercise
Time Frame: Before and after three months of exercise training
proteomics
Before and after three months of exercise training
Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise
Time Frame: Before and after three months of exercise training
Collect exhaled gas and use mass spectrometry for small molecule detection
Before and after three months of exercise training
Changes from Baseline Attention performance after 3 months of exercise
Time Frame: Before and after three months of exercise training
Attention Survey Questionnaire
Before and after three months of exercise training
Changes from Baseline Sleep Quality after 3 months of exercise
Time Frame: Before and after three months of exercise training
Wearing a heart rate monitoring watch to collect data
Before and after three months of exercise training
Changes from Baseline Total Thyroid Hormone after 3 months of exercise
Time Frame: Before and after three months of exercise training
Total Thyroid Hormone in nmol/L
Before and after three months of exercise training
Changes from Baseline Liver steatosis after 3 months of exercise
Time Frame: Before and after three months of exercise training
Abdominal ultrasound evaluation of the presence of hepatic steatosis
Before and after three months of exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2021263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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