Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00178633
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heinrich.taegtmeyer@uth.tmc.edu', 'phone': '713 500-6569', 'title': 'Heinrich Taegtmeyer, MD, DPhil, Principal Investigator', 'organization': 'University of Texas Medical School at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected at both 9 months and 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Bariatric Surgery, Follow up at 9 Months', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bariatric Surgery, Follow up at 2 Years', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bariatric Surgery', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.'}], 'classes': [{'title': '0-3 Months Post Procedure', 'categories': [{'measurements': [{'value': '-21.5', 'spread': '18.1', 'groupId': 'OG000', 'lowerLimit': '-25.0', 'upperLimit': '-18.1'}]}]}, {'title': '3-9 Months Post Procedure', 'categories': [{'measurements': [{'value': '-16.4', 'groupId': 'OG000', 'lowerLimit': '-20.1', 'upperLimit': '-12.8'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 9 months', 'description': 'Change in weight. Negative values represent weight loss.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'broken out into 0-3months and 3-9months below'}, {'type': 'SECONDARY', 'title': 'Change in Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bariatric Surgery', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.'}], 'classes': [{'title': '0-3 Months', 'categories': [{'measurements': [{'value': '-19.1', 'groupId': 'OG000', 'lowerLimit': '-33.2', 'upperLimit': '-5.0'}]}]}, {'title': '3-9 Months', 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '7.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-9 Months', 'description': 'Change in glucose. Negative values represent a decrease in glucose levels.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'broken out into 0-3months and 3-9months below'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Doppler Diastolic Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bariatric Surgery', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.'}], 'classes': [{'title': '0-3 Months', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-.06', 'upperLimit': '1.3'}]}]}, {'title': '3-9 Months', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-9 Months', 'description': 'Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.', 'unitOfMeasure': 'cm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis broken down into 0-3 months and 3-9 months'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bariatric Surgery', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.'}], 'classes': [{'title': '0-3 Month', 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '0.1'}]}]}, {'title': '3-9 Month', 'categories': [{'measurements': [{'value': '-6.3', 'groupId': 'OG000', 'lowerLimit': '-10.2', 'upperLimit': '-2.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-9 Months', 'description': 'Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.', 'unitOfMeasure': 'g/m^2.7', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'broken out into 0-3months and 3-9months below'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bariatric Surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'IRB Approved to begin recruitment, 5.20.2004. Enrollment ended June 2006. All patients recruited from University of Texas Houston, Bariatric Surgery Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bariatric Surgery', 'description': 'Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '43 patients were originally enrolled, and 37 participated through 9 months; 15 female participants returned for an additional 2 year analysis.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Skeletal muscle biopsies, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-03', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': '0 to 9 months', 'description': 'Change in weight. Negative values represent weight loss.'}], 'secondaryOutcomes': [{'measure': 'Change in Glucose', 'timeFrame': '0-9 Months', 'description': 'Change in glucose. Negative values represent a decrease in glucose levels.'}, {'measure': 'Change in Tissue Doppler Diastolic Velocity', 'timeFrame': '0-9 Months', 'description': 'Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.'}, {'measure': 'Change in Left Ventricular Mass', 'timeFrame': '0-9 Months', 'description': 'Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin Resistance', 'Free Fatty Acids', 'Heart Failure'], 'conditions': ['Obesity', 'Diabetes', 'Heart Failure', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '17138229', 'type': 'RESULT', 'citation': 'Leichman JG, Aguilar D, King TM, Mehta S, Majka C, Scarborough T, Wilson EB, Taegtmeyer H. Improvements in systemic metabolism, anthropometrics, and left ventricular geometry 3 months after bariatric surgery. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):592-9. doi: 10.1016/j.soard.2006.09.005.'}, {'pmid': '16895880', 'type': 'RESULT', 'citation': 'Leichman JG, Aguilar D, King TM, Vlada A, Reyes M, Taegtmeyer H. Association of plasma free fatty acids and left ventricular diastolic function in patients with clinically severe obesity. Am J Clin Nutr. 2006 Aug;84(2):336-41. doi: 10.1093/ajcn/84.1.336.'}, {'pmid': '18954843', 'type': 'RESULT', 'citation': 'Leichman JG, Wilson EB, Scarborough T, Aguilar D, Miller CC 3rd, Yu S, Algahim MF, Reyes M, Moody FG, Taegtmeyer H. Dramatic reversal of derangements in muscle metabolism and left ventricular function after bariatric surgery. Am J Med. 2008 Nov;121(11):966-73. doi: 10.1016/j.amjmed.2008.06.033.'}, {'pmid': '19375553', 'type': 'RESULT', 'citation': 'Trakhtenbroit MA, Leichman JG, Algahim MF, Miller CC 3rd, Moody FG, Lux TR, Taegtmeyer H. Body weight, insulin resistance, and serum adipokine levels 2 years after 2 types of bariatric surgery. Am J Med. 2009 May;122(5):435-42. doi: 10.1016/j.amjmed.2008.10.035.'}, {'pmid': '20394883', 'type': 'RESULT', 'citation': 'Taegtmeyer H, Leichman JG, Reyes M, Lux TR. Early benefits from weight-loss surgery. J Am Coll Cardiol. 2010 Apr 20;55(16):1754; author reply 1754. doi: 10.1016/j.jacc.2009.11.081. No abstract available.'}, {'pmid': '16598541', 'type': 'RESULT', 'citation': 'Leichman JG, Lavis VR, Aguilar D, Wilson CR, Taegtmeyer H. The metabolic syndrome and the heart--a considered opinion. Clin Res Cardiol. 2006 Jan;95 Suppl 1:i134-41. doi: 10.1007/s00392-006-1119-7.'}, {'pmid': '19356463', 'type': 'RESULT', 'citation': 'Taegtmeyer H, Algahim MF. Obesity and cardiac metabolism in women. JACC Cardiovasc Imaging. 2008 Jul;1(4):434-5. doi: 10.1016/j.jcmg.2008.04.008. No abstract available.'}, {'pmid': '20111021', 'type': 'RESULT', 'citation': 'Burgmaier M, Sen S, Philip F, Wilson CR, Miller CC 3rd, Young ME, Taegtmeyer H. Metabolic adaptation follows contractile dysfunction in the heart of obese Zucker rats fed a high-fat "Western" diet. Obesity (Silver Spring). 2010 Oct;18(10):1895-901. doi: 10.1038/oby.2009.500. Epub 2010 Jan 28.'}, {'pmid': '20093477', 'type': 'RESULT', 'citation': 'Harmancey R, Wilson CR, Wright NR, Taegtmeyer H. Western diet changes cardiac acyl-CoA composition in obese rats: a potential role for hepatic lipogenesis. J Lipid Res. 2010 Jun;51(6):1380-93. doi: 10.1194/jlr.M001230. Epub 2010 Jan 21.'}, {'pmid': '20569762', 'type': 'RESULT', 'citation': 'Algahim MF, Lux TR, Leichman JG, Boyer AF, Miller CC 3rd, Laing ST, Wilson EB, Scarborough T, Yu S, Snyder B, Wolin-Riklin C, Kyle UG, Taegtmeyer H. Progressive regression of left ventricular hypertrophy two years after bariatric surgery. Am J Med. 2010 Jun;123(6):549-55. doi: 10.1016/j.amjmed.2009.11.020.'}, {'pmid': '20676734', 'type': 'RESULT', 'citation': 'Ballal K, Wilson CR, Harmancey R, Taegtmeyer H. Obesogenic high fat western diet induces oxidative stress and apoptosis in rat heart. Mol Cell Biochem. 2010 Nov;344(1-2):221-30. doi: 10.1007/s11010-010-0546-y. Epub 2010 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only 15 patients completed 24 month evaluations due to 28 patients unwilling to return.\n\nThe overarching purpose appears to have been not only evaluation of weightloss, but normalization of metabolic profile over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects in this study will represent both male and female patients with clinically severe obesity (BMI \\> 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. Patients are screened through the University of Texas Houston Bariatric Surgery Center (UTHBSC) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with Roux-en-Y (SPGB), or laparoscopic adjustable gastric banding (LAGB). Adults (\\>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the UTHBSC. Candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study.\n\nPatients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. .\n\nExclusion Criteria: Exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. This study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00178633', 'briefTitle': 'Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'HSC-MS-02-137'}, 'secondaryIdInfos': [{'id': '5R01HL073162-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL073162-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bariatric Surgery', 'description': 'Procedures were not part of the trial. Patients already undergoing these clinical procedures agreed to analysis and follow-up for research purposes. All patients had one of two different types of procedures, but outcome analyses did not distinguish between the two procedures.', 'interventionNames': ['Procedure: Bariatric surgery']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.', 'armGroupLabels': ['Bariatric Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Health Sciences Center Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Heinrich Taegtmeyer, MD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Health Sciences Center Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}