Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-27 @ 11:30 AM
Study NCT ID:
NCT03800160
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2018-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Greater China Metabolic and Bariatric Surgery Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the excess weight loss effect of different metabolic surgeries after 1year', 'timeFrame': '1 year after surgery', 'description': 'Percent excess weight loss (%EWL), %EWL=\\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)'}], 'secondaryOutcomes': [{'measure': 'the adverse events rate of different metabolic surgeries', 'timeFrame': '30 days after surgery', 'description': 'show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）'}, {'measure': 'the excess weight loss effect of metabolic surgery with long-time follow-ups', 'timeFrame': '3 years', 'description': 'Percent excess weight loss (%EWL), %EWL=\\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)'}, {'measure': 'the excess weight loss effect of metabolic surgery with long-time follow-ups', 'timeFrame': '5 years', 'description': 'Percent excess weight loss (%EWL), %EWL=\\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)'}, {'measure': 'the excess weight loss effect of metabolic surgery with long-time follow-ups', 'timeFrame': '10 years', 'description': 'Percent excess weight loss (%EWL), %EWL=\\[(initial weight)-(post-op weight)\\]/\\[(initial weight)-(ideal weight)\\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)'}, {'measure': 'the glycemic control level of metabolic surgery with long-time follow-ups', 'timeFrame': '1 year after surgery', 'description': 'the change of HbA1c, glucose level, C-peptide and insulin levels'}, {'measure': 'the glycemic control level of metabolic surgery with long-time follow-ups', 'timeFrame': '3 year after surgery', 'description': 'the change of HbA1c, glucose level, C-peptide and insulin levels'}, {'measure': 'the glycemic control level of metabolic surgery with long-time follow-ups', 'timeFrame': '5 year after surgery', 'description': 'the change of HbA1c, glucose level, C-peptide and insulin levels'}, {'measure': 'the glycemic control level of metabolic surgery with long-time follow-ups', 'timeFrame': '10 year after surgery', 'description': 'the change of HbA1c, glucose level, C-peptide and insulin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic surgery', 'metabolic disease', 'multicenter'], 'conditions': ['Metabolic Surgery']}, 'descriptionModule': {'briefSummary': 'Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be able to receive metabolic surgery, including but not limit to LSG and LRYGB\n\nExclusion Criteria:\n\n* can not be able to understand and willing to participate in this registry with signature'}, 'identificationModule': {'nctId': 'NCT03800160', 'briefTitle': 'Greater China Metabolic and Bariatric Surgery Database', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Greater China Metabolic and Bariatric Surgery Database', 'orgStudyIdInfo': {'id': 'GC-MBD'}}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Shijitan Hospital, Capital Medical University', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Shanxi Dayi Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': "Inner Mongolia People's Hospital", 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': "The Second People's Hospital of Xinxiang Henan", 'class': 'UNKNOWN'}, {'name': 'Tangshan Gongren Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Nankai Hospital', 'class': 'OTHER'}, {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of general surgery, principal investigator', 'investigatorFullName': 'Zhongtao Zhang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}