Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04984005
Status:
UNKNOWN
Last Update Posted:
2023-06-23
First Post:
2021-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 366}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-25', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from Baseline Obesity Indicators after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'BMI in kg/m\\^2'}, {'measure': 'Changes from Baseline Body Fat Composition after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Body fat composition (%)'}, {'measure': 'Changes from Baseline Peak Metabolic Equivalent after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Peak Metabolic Equivalent in MET'}, {'measure': 'Changes from Baseline Blood Pressure after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Blood pressure in mmHg'}, {'measure': 'Changes from Baseline Fasting Blood Glucose after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Fasting Blood Glucose in mmol/L'}, {'measure': 'Changes from Baseline Total Serum Cholesterol after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Total Serum Cholesterol in mmol/L'}, {'measure': 'Changes from Baseline Triglyceride after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Triglyceride in mmol/L'}, {'measure': 'Changes from Baseline Serum High-density Lipoprotein Cholesterol after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Serum High-density Lipoprotein Cholesterol in mmol/L'}, {'measure': 'Changes from Baseline Serum Low-density Lipoprotein Cholesterol after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Serum Low-density Lipoprotein Cholesterol in mmol/L'}, {'measure': 'Changes from Baseline Sexual Hormones after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Detection of hormone indicators related to growth and development'}], 'secondaryOutcomes': [{'measure': 'Changes from Baseline Exercise Performance after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'VO2max/Kg in mL/min/Kg'}, {'measure': 'Changes from Baseline Hepatic Hemodynamic Index after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'wall shear stress in proper hepatic artery，Pa'}, {'measure': 'Changes from Baseline Bone Mineral Density after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Using ultrasound bone density instruments for detection'}, {'measure': 'Changes from Baseline C-reactive protein after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Inflammatory Biomarker C-reactive protein in mg/L'}, {'measure': 'Changes from Baseline Oxidative Stress Biomarkers after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Oxidative Stress Biomarker MDA in nmol/mL'}, {'measure': 'Changes from Baseline Serum Metabolomics after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Metabolomics'}, {'measure': 'Changes from Baseline Oral and Gut Microbiome after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'oral and gut microbiome'}, {'measure': 'Changes from Baseline Viromics after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'viromics'}, {'measure': 'Exome sequencing and genome sequencing', 'timeFrame': 'At baseline', 'description': 'genetics'}, {'measure': 'Changes from Baseline Proteomics after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'proteomics'}, {'measure': 'Changes from Baseline Volatile Organic Compounds in Breath after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Collect exhaled gas and use mass spectrometry for small molecule detection'}, {'measure': 'Changes from Baseline Attention performance after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Attention Survey Questionnaire'}, {'measure': 'Changes from Baseline Sleep Quality after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Wearing a heart rate monitoring watch to collect data'}, {'measure': 'Changes from Baseline Total Thyroid Hormone after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Total Thyroid Hormone in nmol/L'}, {'measure': 'Changes from Baseline Liver steatosis after 3 months of exercise', 'timeFrame': 'Before and after three months of exercise training', 'description': 'Abdominal ultrasound evaluation of the presence of hepatic steatosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children and adolescents', 'Obesity', 'metabolic syndrome', 'overweight', 'exercise'], 'conditions': ['Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of overweight or obesity or metabolic syndrome;\n* Good academic performance in school;\n* Willing to sign informed consent.\n\nExclusion Criteria:\n\n* Clinical diagnosis of Cushing syndrome;\n* Pathological obesity such as Prader-Willi syndrome and obesity caused by drug factors；\n* Participated in other intervention studies within the previous three months;\n* participant or their guardian has obvious intellectual or mental abnormalities.'}, 'identificationModule': {'nctId': 'NCT04984005', 'briefTitle': 'The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Interaction and Regulation Mechanism of Different Exercise Patterns With Metabolic Syndrome and Related Metabolic Diseases', 'orgStudyIdInfo': {'id': 'M2021263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low intensity exercise training group', 'interventionNames': ['Behavioral: Low intensity exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity exercise training group', 'interventionNames': ['Behavioral: Moderate intensity exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent high intensity exercise training group', 'interventionNames': ['Behavioral: Intermittent high intensity exercise training']}], 'interventions': [{'name': 'Low intensity exercise training', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Low intensity exercise training group']}, {'name': 'Moderate intensity exercise training', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Moderate intensity exercise training group']}, {'name': 'Intermittent high intensity exercise training', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Intermittent high intensity exercise training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiyi Yu, Dr', 'role': 'CONTACT', 'email': 'yuhaiyi@bjmu.edu.cn', 'phone': '008613466615475'}, {'name': 'Ming Xu, Prof', 'role': 'CONTACT', 'email': 'xuminghi@bjmu.edu.cn', 'phone': '008613683388938'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Haiyi Yu, Dr.', 'role': 'CONTACT', 'email': 'yuhaiyi@bjmu.edu.cn', 'phone': '0086013466615475'}, {'name': 'Ming Xu, Prof.', 'role': 'CONTACT', 'email': 'xuminghi@bjmu.edu.cn', 'phone': '0086013683388938'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}