Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-27 @ 5:50 PM
Study NCT ID:
NCT01785134
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Different Surgical Methods to Treat Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Erik.Naslund@ki.se', 'phone': '+46812355017', 'title': 'Dr Erik Näslund', 'organization': 'Karolinska Institutet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'OG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'description': 'Insulin sensitivity measured by hyperinsulinemic euglycemic clamp', 'unitOfMeasure': 'glucose/kg body weight/min', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Body Composition at Two Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'OG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '8', 'groupId': 'OG000'}, {'value': '38', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'unitOfMeasure': '% body fat', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Blood Pressure at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'OG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'spread': '16', 'groupId': 'OG000'}, {'value': '121', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'unitOfMeasure': 'mm Hg systolic', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Body Mass Index at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'OG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'unitOfMeasure': 'Kg/meter squared', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Blood Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'OG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'unitOfMeasure': 'P-Cholesterol mmol/L', 'dispersionType': 'Standard Deviation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'FG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Gastric bypass operation without omentectomy.\n\nGastric bypass operation'}, {'id': 'BG001', 'title': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum\n\nOmentectomy\n\nGastric bypass operation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '9', 'groupId': 'BG000'}, {'value': '43', 'spread': '9', 'groupId': 'BG001'}, {'value': '42', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-28', 'studyFirstSubmitDate': '2013-01-30', 'resultsFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-28', 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity at 2 Years', 'timeFrame': '2 years postoperative', 'description': 'Insulin sensitivity measured by hyperinsulinemic euglycemic clamp'}], 'secondaryOutcomes': [{'measure': 'Body Composition at Two Years', 'timeFrame': '2 years postoperative'}, {'measure': 'Blood Pressure at 2 Years', 'timeFrame': '2 years postoperative'}, {'measure': 'Body Mass Index at 2 Years', 'timeFrame': '2 years postoperative'}, {'measure': 'Blood Lipids', 'timeFrame': '2 years postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Bariatric Surgery', 'Insulin Sensitivity'], 'conditions': ['Obesity', 'Type 2 Diabetes', 'Insulin Sensitivity']}, 'referencesModule': {'references': [{'pmid': '33560372', 'type': 'DERIVED', 'citation': 'van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.'}, {'pmid': '24485000', 'type': 'DERIVED', 'citation': 'Andersson DP, Thorell A, Lofgren P, Wiren M, Toft E, Qvisth V, Riserus U, Berglund L, Naslund E, Bringman S, Thorne A, Arner P, Hoffstedt J. Omentectomy in addition to gastric bypass surgery and influence on insulin sensitivity: a randomized double blind controlled trial. Clin Nutr. 2014 Dec;33(6):991-6. doi: 10.1016/j.clnu.2014.01.004. Epub 2014 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBody mass index over 40 kg/m2\n\nBody mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01785134', 'acronym': 'DEOSH', 'briefTitle': 'Effects of Different Surgical Methods to Treat Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Metabolic Effects of Different Surgical Methods to Treat Obesity', 'orgStudyIdInfo': {'id': 'CT20110061'}, 'secondaryIdInfos': [{'id': 'CT20110061', 'type': 'REGISTRY', 'domain': 'Karolinska Clinical Trial Registration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Gastric bypass operation without omentectomy.', 'interventionNames': ['Procedure: Gastric bypass operation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omentectomy', 'description': 'Gastric bypass operation in conjunction with removal of greater omentum', 'interventionNames': ['Procedure: Omentectomy', 'Procedure: Gastric bypass operation']}], 'interventions': [{'name': 'Omentectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Omentectomy']}, {'name': 'Gastric bypass operation', 'type': 'PROCEDURE', 'armGroupLabels': ['Control', 'Omentectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15286', 'city': 'Södertälje', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Södertälje Hospital', 'geoPoint': {'lat': 59.19554, 'lon': 17.62525}}, {'zip': '11691', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '14186', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '18288', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Erik Näslund, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Peter Arner, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Johan Hoffstedt, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Erik Näslund', 'investigatorAffiliation': 'Karolinska Institutet'}}}}