Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-13 @ 1:12 PM
Study NCT ID:
NCT06452303
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Patient Cohort for Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': 'Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Height, Weight, Waist Circumference, Hip Circumference', 'Preoperative Laboratory Examination Status', 'Preoperative Routine Examination Results', 'Laboratory and Examination Results During Follow-up']}, 'descriptionModule': {'briefSummary': 'This study is based at the National Integrated Traditional Chinese and Western Medicine Medical Center and leverages the centralized strengths of our department, which integrates multiple disciplines (general surgery, endocrinology, nutrition, exercise, and traditional Chinese medicine). It focuses on key scientific issues in the comprehensive management of bariatric surgery throughout the entire treatment cycle. By recording key indicators of patients before and after surgery and using methods such as machine learning to predict postoperative complications, we aim to enhance precision management. Ultimately, we will establish a refined diagnosis and treatment system for metabolic weight loss surgery, promote its application, and thereby raise the standardized management level of weight loss and metabolic disciplines in our hospital and primary care units nationwide. This will improve patient outcomes and reduce the healthcare burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI \\< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities.\n\n 2、For those with simple obesity, 27.5 ≤ BMI \\< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity.\n\n 3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulin secretion capacity.\n\nExclusion Criteria:\n\n* 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, but whose pancreatic beta-cell function is largely lost, with a BMI \\< 25.0; 3、Age \\< 16 years or age \\> 65 years; 4、Pregnant women with diabetes and patients with certain special types of diabetes; 5、Those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、Those whose expectations for the surgery are not realistic; 7、Those unwilling to assume the risks of potential surgical complications; 8、Those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、Those in poor general health, who are unable to tolerate general anesthesia or surgery.'}, 'identificationModule': {'nctId': 'NCT06452303', 'briefTitle': 'The Patient Cohort for Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'The Patient Cohort for Bariatric Surgery', 'orgStudyIdInfo': {'id': 'PCBS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Meng, doctor', 'role': 'CONTACT', 'email': 'menghuade@hotmail.com', 'phone': '18611457779'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital', 'investigatorFullName': 'Hua Meng', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}