The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Primary Purpose
Obesity, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low intensity exercise training
Moderate intensity exercise training
Intermittent high intensity exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring children and adolescents, Obesity, metabolic syndrome, overweight, exercise
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.
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low intensity exercise training group
Moderate intensity exercise training group
Intermittent high intensity exercise training group
Arm Description
Outcomes
Primary Outcome Measures
Changes from Baseline Obesity Indicators after 3 months of exercise
BMI in kg/m^2
Changes from Baseline Body Fat Composition after 3 months of exercise
Body fat composition (%)
Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise
Peak Metabolic Equivalent in MET
Changes from Baseline Blood Pressure after 3 months of exercise
Blood pressure in mmHg
Changes from Baseline Fasting Blood Glucose after 3 months of exercise
Fasting Blood Glucose in mmol/L
Changes from Baseline Total Serum Cholesterol after 3 months of exercise
Total Serum Cholesterol in mmol/L
Changes from Baseline Triglyceride after 3 months of exercise
Triglyceride in mmol/L
Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise
Serum High-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise
Serum Low-density Lipoprotein Cholesterol in mmol/L
Changes from Baseline Sexual Hormones after 3 months of exercise
Detection of hormone indicators related to growth and development
Secondary Outcome Measures
Changes from Baseline Exercise Performance after 3 months of exercise
VO2max/Kg in mL/min/Kg
Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise
wall shear stress in proper hepatic artery,Pa
Changes from Baseline Bone Mineral Density after 3 months of exercise
Using ultrasound bone density instruments for detection
Changes from Baseline C-reactive protein after 3 months of exercise
Inflammatory Biomarker C-reactive protein in mg/L
Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise
Oxidative Stress Biomarker MDA in nmol/mL
Changes from Baseline Serum Metabolomics after 3 months of exercise
Metabolomics
Changes from Baseline Oral and Gut Microbiome after 3 months of exercise
oral and gut microbiome
Changes from Baseline Viromics after 3 months of exercise
viromics
Exome sequencing and genome sequencing
genetics
Changes from Baseline Proteomics after 3 months of exercise
proteomics
Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise
Collect exhaled gas and use mass spectrometry for small molecule detection
Changes from Baseline Attention performance after 3 months of exercise
Attention Survey Questionnaire
Changes from Baseline Sleep Quality after 3 months of exercise
Wearing a heart rate monitoring watch to collect data
Changes from Baseline Total Thyroid Hormone after 3 months of exercise
Total Thyroid Hormone in nmol/L
Changes from Baseline Liver steatosis after 3 months of exercise
Abdominal ultrasound evaluation of the presence of hepatic steatosis
Full Information
NCT ID
NCT04984005
First Posted
July 21, 2021
Last Updated
June 20, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04984005
Brief Title
The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Official Title
The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome
Keywords
children and adolescents, Obesity, metabolic syndrome, overweight, exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low intensity exercise training group
Arm Type
Experimental
Arm Title
Moderate intensity exercise training group
Arm Type
Experimental
Arm Title
Intermittent high intensity exercise training group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Low intensity exercise training
Intervention Description
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
Intervention Name(s)
Moderate intensity exercise training
Intervention Description
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
Intervention Name(s)
Intermittent high intensity exercise training
Intervention Description
The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a high-intensity exercise training.
Primary Outcome Measure Information:
Title
Changes from Baseline Obesity Indicators after 3 months of exercise
Description
BMI in kg/m^2
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Body Fat Composition after 3 months of exercise
Description
Body fat composition (%)
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise
Description
Peak Metabolic Equivalent in MET
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Blood Pressure after 3 months of exercise
Description
Blood pressure in mmHg
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Fasting Blood Glucose after 3 months of exercise
Description
Fasting Blood Glucose in mmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Total Serum Cholesterol after 3 months of exercise
Description
Total Serum Cholesterol in mmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Triglyceride after 3 months of exercise
Description
Triglyceride in mmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise
Description
Serum High-density Lipoprotein Cholesterol in mmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise
Description
Serum Low-density Lipoprotein Cholesterol in mmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Sexual Hormones after 3 months of exercise
Description
Detection of hormone indicators related to growth and development
Time Frame
Before and after three months of exercise training
Secondary Outcome Measure Information:
Title
Changes from Baseline Exercise Performance after 3 months of exercise
Description
VO2max/Kg in mL/min/Kg
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise
Description
wall shear stress in proper hepatic artery,Pa
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Bone Mineral Density after 3 months of exercise
Description
Using ultrasound bone density instruments for detection
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline C-reactive protein after 3 months of exercise
Description
Inflammatory Biomarker C-reactive protein in mg/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise
Description
Oxidative Stress Biomarker MDA in nmol/mL
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Serum Metabolomics after 3 months of exercise
Description
Metabolomics
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Oral and Gut Microbiome after 3 months of exercise
Description
oral and gut microbiome
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Viromics after 3 months of exercise
Description
viromics
Time Frame
Before and after three months of exercise training
Title
Exome sequencing and genome sequencing
Description
genetics
Time Frame
At baseline
Title
Changes from Baseline Proteomics after 3 months of exercise
Description
proteomics
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise
Description
Collect exhaled gas and use mass spectrometry for small molecule detection
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Attention performance after 3 months of exercise
Description
Attention Survey Questionnaire
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Sleep Quality after 3 months of exercise
Description
Wearing a heart rate monitoring watch to collect data
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Total Thyroid Hormone after 3 months of exercise
Description
Total Thyroid Hormone in nmol/L
Time Frame
Before and after three months of exercise training
Title
Changes from Baseline Liver steatosis after 3 months of exercise
Description
Abdominal ultrasound evaluation of the presence of hepatic steatosis
Time Frame
Before and after three months of exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyi Yu, Dr.
Phone
0086013466615475
Email
yuhaiyi@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Xu, Prof.
Phone
0086013683388938
Email
xuminghi@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyi Yu, Dr
Phone
008613466615475
Email
yuhaiyi@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ming Xu, Prof
Phone
008613683388938
Email
xuminghi@bjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
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