Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00923260
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2009-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omentectomy and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miguelfherrera@gmail.com', 'phone': '(+52) 55 54870208', 'title': 'Dr. Miguel F Herrera', 'organization': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'An important limitation of our study is the small number of studied patients.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Roux-en-Y Gastric Bypass Alone', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pancreatic Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeSH 2008'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '16.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '40', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.86', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Body Mass Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '30.7', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '131.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '134.6', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '20', 'groupId': 'OG000'}, {'value': '116.7', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '115.6', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '115', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '108.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '125', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '116.7', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '124.3', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '85.5', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '89', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '75', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '81.3', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '99.8', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '105', 'spread': '35.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '88.3', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Components of Metabolic Syndrome (Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'OG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '85.5', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 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'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'FG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "Patient didn't complete the follow-up period after surgery", 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': "Patient didn't complete the follow-up period after surgery", 'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients from the obesity clinic were recruited from November 2005 to October 2006'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Roux-en-Y Gastric Bypass/Omentectomy'}, {'id': 'BG001', 'title': 'Roux-en-Y Gastric Bypass Alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-01-28', 'resultsFirstSubmitDate': '2009-01-28', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-30', 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Components of Metabolic Syndrome (Body Mass Index)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Body Mass Index)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Body Mass Index)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Body Mass Index)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Body Mass Index)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Systolic Blood Pressure)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Diastolic Blood Pressure)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Glucose)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Glucose)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Glucose)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Glucose)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Glucose)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Insulin)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Insulin)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Insulin)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Insulin)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Total Cholesterol)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Total Cholesterol)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Total Cholesterol)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Total Cholesterol)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Total Cholesterol)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Triglycerides)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Triglycerides)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Triglycerides)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Triglycerides)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Triglycerides)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Low-Density Lipoproteins)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Low-Density Lipoproteins)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Low-Density Lipoproteins)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Low-Density Lipoproteins)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (Low-Density Lipoproteins)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (High-Density Lipoproteins)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (High-Density Lipoproteins)', 'timeFrame': '1 month', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (High-Density Lipoproteins)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (High-Density Lipoproteins)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Components of Metabolic Syndrome (High-Density Lipoproteins)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}], 'secondaryOutcomes': [{'measure': 'Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Leptin)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Leptin)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Leptin)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Leptin)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Adiponectin)', 'timeFrame': 'Basal', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Adiponectin)', 'timeFrame': '3 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Adiponectin)', 'timeFrame': '6 months', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}, {'measure': 'Acute Phase Reactants and Inflammatory Mediators (Adiponectin)', 'timeFrame': '1 year', 'description': 'Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Omentectomy', 'metabolic syndrome', 'acute phase reactants'], 'conditions': ['Metabolic Syndrome', 'Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '20587720', 'type': 'DERIVED', 'citation': 'Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.', 'detailedDescription': 'Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 35 Kg/m2\n* Metabolic syndrome diagnosed\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Uncontrolled type 2 diabetes\n* Cirrhosis or active hepatitis\n* Pregnancy\n* Recent MI or stroke'}, 'identificationModule': {'nctId': 'NCT00923260', 'briefTitle': 'Omentectomy and Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial', 'orgStudyIdInfo': {'id': 'INCMNSZ-1486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Roux-en-Y Gastric Bypass/Omentectomy', 'description': 'Laparoscopic Roux-en-Y Gastric Bypass with omentectomy', 'interventionNames': ['Procedure: Laparoscopic Roux-en-Y Gastric Bypass', 'Procedure: Omentectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Roux-en-Y Gastric Bypass alone', 'interventionNames': ['Procedure: Laparoscopic Roux-en-Y Gastric Bypass']}], 'interventions': [{'name': 'Laparoscopic Roux-en-Y Gastric Bypass', 'type': 'PROCEDURE', 'description': 'Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.', 'armGroupLabels': ['Roux-en-Y Gastric Bypass alone', 'Roux-en-Y Gastric Bypass/Omentectomy']}, {'name': 'Omentectomy', 'type': 'PROCEDURE', 'description': 'After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.', 'armGroupLabels': ['Roux-en-Y Gastric Bypass/Omentectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Miguel F Herrrera, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Miguel Francisco Herrera', 'oldOrganization': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}