Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 3:59 AM
Study NCT ID:
NCT06275061
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Obesity and MEtabolic Surgery Database (COMES Database)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053858', 'term': 'Metabolic Networks and Pathways'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events rate of metabolic and bariatric surgery', 'timeFrame': '30 days after surgery', 'description': 'Surgical safety by 30 days follow-up according to guideline'}], 'primaryOutcomes': [{'measure': 'Excess weight loss effect of metabolic and bariatric surgery after 1 year', 'timeFrame': '1 year', 'description': 'Percent excess weight loss (%EWL) = \\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\]'}], 'secondaryOutcomes': [{'measure': 'Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '3 years', 'description': 'Percent excess weight loss (%EWL) = \\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\]'}, {'measure': 'Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '5 years', 'description': 'Percent excess weight loss (%EWL) = \\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\]'}, {'measure': 'Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '10 years', 'description': 'Percent excess weight loss (%EWL) = \\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\]'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery after 1 year', 'timeFrame': '1 year', 'description': 'Change of HbA1c levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '3 years', 'description': 'Change of HbA1c levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '5 years', 'description': 'Change of HbA1c levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '10 years', 'description': 'Change of HbA1c levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery after 1 year', 'timeFrame': '1 year', 'description': 'Change of blood glucose levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '3 years', 'description': 'Change of blood glucose levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '5 years', 'description': 'Change of blood glucose levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '10 years', 'description': 'Change of blood glucose levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery after 1 year', 'timeFrame': '1 year', 'description': 'Change of C-peptide levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '3 years', 'description': 'Change of C-peptide levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '5 years', 'description': 'Change of C-peptide levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '10 years', 'description': 'Change of C-peptide levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery after 1 year', 'timeFrame': '1 year', 'description': 'Change of insulin levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '3 years', 'description': 'Change of insulin levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '5 years', 'description': 'Change of insulin levels'}, {'measure': 'Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups', 'timeFrame': '10 years', 'description': 'Change of insulin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Metabolic Surgery', 'Bariatric Surgery', 'Weight Loss'], 'conditions': ['Obesity', 'Metabolic Surgery', 'Bariatric Surgery', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the Chinese Obesity and MEtabolic Surgery Database (COMES Database) is to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population.', 'detailedDescription': 'COMES Database is a prospective managed national database to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as obesity undergoing metabolic and bariatric surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as obesity undergoing metabolic and bariatric surgery.\n\nExclusion Criteria:\n\n* Patients treated by non-surgical modalities.'}, 'identificationModule': {'nctId': 'NCT06275061', 'acronym': 'COMES', 'briefTitle': 'Chinese Obesity and MEtabolic Surgery Database (COMES Database)', 'organization': {'class': 'OTHER', 'fullName': 'Jinan University Guangzhou'}, 'officialTitle': 'Chinese Obesity and MEtabolic Surgery Database', 'orgStudyIdInfo': {'id': 'KY-2020-021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metabolic and Bariatric Surgery', 'description': 'Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.', 'interventionNames': ['Procedure: Metabolic and Bariatric Surgery']}], 'interventions': [{'name': 'Metabolic and Bariatric Surgery', 'type': 'PROCEDURE', 'description': 'Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.', 'armGroupLabels': ['Metabolic and Bariatric Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wah Yang, MD', 'role': 'CONTACT', 'email': 'yangwah@qq.com', 'phone': '+8615920373823'}], 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wah Yang, MD', 'role': 'CONTACT', 'email': 'yangwah@qq.com', 'phone': '+8615920373823'}], 'overallOfficials': [{'name': 'Cunchuan Wang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Jinan University'}, {'name': 'Wah Yang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Jinan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinan University Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Obesity and Metabolic Surgery Collaborative', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wah Yang, MD', 'investigatorAffiliation': 'Jinan University Guangzhou'}}}}