Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-04-17 @ 10:08 PM
Study NCT ID:
NCT02271568
Status:
UNKNOWN
Last Update Posted:
2016-02-19
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-19', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glomerular filtration rate', 'timeFrame': 'prior to surgery - 1, 3, 6, 12month after surgery'}], 'secondaryOutcomes': [{'measure': 'Change in excessive body weight', 'timeFrame': '1, 3, 6, 12month after surgery'}, {'measure': 'Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function)', 'timeFrame': 'Before and 12month after surgery'}, {'measure': '24 hours ambulatory blood pressure', 'timeFrame': 'prior to surgery - 1, 3, 6, 12month after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.', 'detailedDescription': 'Metabolic syndrome is strongly associated with obesity and the patients with this syndrome are at increased risk for cardiovascular disease.\n\nObesity constitutes a strong risk factor for the development of chronic kidney disease. Among diabetics, obesity is known to amplify the risk for kidney disease.\n\nBariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome. In addition, many observational studies have demonstrated significant reduction in proteinuria after bariatric surgery.\n\nHowever, the changes in the component of cardiovascular problem among metabolic syndrome and changes in renal filtration function or progression to end stage kidney disease in morbidly obese patients after weight loss surgery have not been extensively studied. Therefore, our study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '15 Obese patients (BMI\\>30) having one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) and morbid obese patients (BMI\\>35) accepted for bariatric surgery. 15 matched controls.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obesity (BMI\\>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)\n* Morbid obese patients (BMI\\>35)\n\nExclusion Criteria:\n\n* Prior bariatric surgery\n* Malignancy (any type)\n* End stage renal disease'}, 'identificationModule': {'nctId': 'NCT02271568', 'briefTitle': 'Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Change in Glomerular Filtration Rate and 24 Hours Ambulatory Blood Pressure After Gastric Bypass Surgery Versus Conventional Weight Loss in Morbid Obesity.', 'orgStudyIdInfo': {'id': 'HYUH 2013-07-024-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients', 'description': '15 Obese patients (BMI\\>30) having one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) and morbid obese patients (BMI\\>35) accepted for bariatric surgery.', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'Control patients', 'description': '15 matched controls receiving Intensive medical therapy', 'interventionNames': ['Other: Intensive medical therapy']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic or Robot R-Y gastric bypass', 'armGroupLabels': ['Obese patients']}, {'name': 'Intensive medical therapy', 'type': 'OTHER', 'description': 'intensive medical therapy according to published guidelines by ADA and EASD', 'armGroupLabels': ['Control patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133-792', 'city': 'Seongdong-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital'}], 'overallOfficials': [{'name': 'Tae Kyung Ha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University Seoul Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tae Kyung Ha', 'investigatorAffiliation': 'Hanyang University'}}}}