Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-29 @ 5:40 PM
Study NCT ID:
NCT05363059
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2022-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D000959', 'term': 'Antihypertensive Agents'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in metabolic parameters from baseline to 5 years.', 'timeFrame': 'baseline to 5 years', 'description': 'Waist circumference(cm)'}, {'measure': 'Change in metabolic parameters from baseline to 5 years.', 'timeFrame': 'baseline to 5 years', 'description': 'body mass index(kg/m\\^2)'}], 'secondaryOutcomes': [{'measure': 'Change in glycosylated hemoglobin from baseline to 5 years.', 'timeFrame': 'baseline to 5 years', 'description': 'glycosylated hemoglobin(%)'}, {'measure': 'Change in plasma glucose from baseline to 5 years.', 'timeFrame': 'baseline to 5 years', 'description': 'Fasting plasma glucose(mmol/l),'}, {'measure': 'Change in blood lipids from baseline to 5 years.', 'timeFrame': 'baseline to 5 years', 'description': 'total cholesterol(mmol/l), triglycerides(mmol/l), high-density lipoprotein cholesterol(mmol/l), low-density lipoprotein cholesterol(mmol/l)'}, {'measure': 'Changes of CVD risk', 'timeFrame': 'baseline to 5 years', 'description': '10-year and lifetime ASCVD risk calculated by the China-PAR equation. Evaluation metrics include sex, age, region of residence (South or North), waist circumference, total cholesterol, HDL cholesterol, systolic blood pressure, diastolic blood pressure, whether taking antihypertensive drugs, whether diabetic, whether smoker, family history of cardiovascular and cerebrovascular.'}, {'measure': 'Hypoglycemic drugs use', 'timeFrame': 'baseline to 5 years', 'description': 'The number and daily drug dose of hypoglycemic drugs'}, {'measure': 'Antihypertensive drugs use', 'timeFrame': 'baseline to 5 years', 'description': 'The number and daily drug dose of antihypertensive drugs'}, {'measure': 'Lipid-lowering drugs use', 'timeFrame': 'baseline to 5 years', 'description': 'The number and daily drug dose of lipid-lowering drugs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'Medical therapy', 'Bariatric surgery', 'body mass index'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). This study aimed to assess the effect of bariatric surgery on MS in patients with low BMI by comparing BS (BMI\\<35 kg/m2 and BMI≥35 kg/m2) with MT (BMI\\<35 kg/m2). A retrospective study including patients with MS undergoing bariatric surgery and medical therapy at a single institution. We follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of MS, its individual components, atherosclerotic cardiovascular disease (ASCVD) risk, and medication used.', 'detailedDescription': '1. Study design and patients\n\n This study aimed to compare bariatric surgery(BS) with medical therapy (MT) for the management of low BMI patients with MS, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. All patients met the Chinese guidelines developed by the Chinese Society for Metabolic \\& Bariatric surgery (CSMBS). All patients achieve diagnostic criteria for MS, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (JIS) definition.\n2. outcome and Data collection\n\n All patients follow up the change of improvement in MS and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term CVD risk, and medication use\n3. Treatments\n\n3.1 BS group The bariatric surgical procedures performed included Roux-en-Y gastric bypass and sleeve gastrectomy.\n\n3.2 MT group According to the guidelines in China, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin\\<7%; systolic blood pressure\\<140 mmHg, diastolic blood pressure\\<80 mmHg; low-density lipoprotein cholesterol\\<2.6 mmol/L; and high-density lipoprotein cholesterol\\>1.3 mmol/L for female or 1.0 mmol/L for male.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n * BMI\\<35 kg/m\\^2\n * Underwent bariatric surgery or medical therapy\n * Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)\n2. Exclusion Criteria:\n\n * Patients who failed to follow up\n * Insulin dependent diabetes\n * congenital dementia\n * brain trauma\n * epileps\n * severe hypoglycemic coma\n * cerebrovascular disease\n * ischemic\n * heart disease\n * renal dysfunction\n * alcohol abuse\n * mental illness\n * psychoactive substance abuse\n * unwillingness to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05363059', 'acronym': 'EBSMTMS', 'briefTitle': 'Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Army Medical University', 'orgStudyIdInfo': {'id': 'EBSMTMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BS group', 'description': 'The group of bariatric surgery therapy in metabolic syndrome patients.', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'MT group', 'description': 'The group of medical therapy in metabolic syndrome patients', 'interventionNames': ['Drug: Hypoglycemic drugs']}], 'interventions': [{'name': 'Hypoglycemic drugs', 'type': 'DRUG', 'otherNames': ['antihypertensive drugs', 'lipid-lowering drugs'], 'description': 'drug', 'armGroupLabels': ['MT group']}, {'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'otherNames': ['metabolic surgery'], 'description': 'surgery', 'armGroupLabels': ['BS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Ke, master', 'role': 'CONTACT', 'email': '494086589@qq.com', 'phone': '18983286542'}, {'name': 'Mei Zhou, master', 'role': 'CONTACT', 'email': 'zhouxunmei_ms@163.com', 'phone': '18580718470'}], 'facility': 'Stryker Laparoscopy', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital', 'investigatorFullName': 'Zhiming Zhu', 'investigatorAffiliation': 'Third Military Medical University'}}}}