Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00273104
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2006-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2006-01-05', 'studyFirstSubmitQcDate': '2006-01-05', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of co-morbidities', 'timeFrame': '1-year after treatment start', 'description': '1-year comparative nonrandomized controlled trial'}], 'secondaryOutcomes': [{'measure': 'Safety issues', 'timeFrame': '1-year', 'description': 'Surgical complications and serious adverse events in both groups as published'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Diabetes Mellitus', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '27619215', 'type': 'DERIVED', 'citation': 'Gabrielsen AM, Omland T, Brokner M, Fredheim JM, Jordan J, Lehmann S, Lund MB, Hjelmesaeth J, Hofso D. The effect of surgical and non-surgical weight loss on N-terminal pro-B-type natriuretic peptide and its relation to obstructive sleep apnea and pulmonary function. BMC Res Notes. 2016 Sep 13;9(1):440. doi: 10.1186/s13104-016-2241-x.'}, {'pmid': '26300987', 'type': 'DERIVED', 'citation': 'Hofso D, Birkeland KI, Holst JJ, Bollerslev J, Sandbu R, Roislien J, Hjelmesaeth J. Gastric bypass surgery has a weight-loss independent effect on post-challenge serum glucose levels. Diabetol Metab Syndr. 2015 Aug 22;7:69. doi: 10.1186/s13098-015-0066-8. eCollection 2015.'}, {'pmid': '25586626', 'type': 'DERIVED', 'citation': 'Gabrielsen AM, Lund MB, Kongerud J, Viken KE, Roislien J, Hjelmesaeth J, Hofso D. Pulmonary function and blood gases after gastric bypass and lifestyle intervention: a comparative study. Clin Obes. 2013 Oct;3(5):117-23. doi: 10.1111/cob.12024. Epub 2013 Jul 8.'}, {'pmid': '23406190', 'type': 'DERIVED', 'citation': 'Karlsen TI, Lund RS, Roislien J, Tonstad S, Natvig GK, Sandbu R, Hjelmesaeth J. Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study. Health Qual Life Outcomes. 2013 Feb 13;11:17. doi: 10.1186/1477-7525-11-17.'}, {'pmid': '22261295', 'type': 'DERIVED', 'citation': 'Nordstrand N, Hertel JK, Hofso D, Sandbu R, Saltvedt E, Roislien J, Os I, Hjelmesaeth J. A controlled clinical trial of the effect of gastric bypass surgery and intensive lifestyle intervention on nocturnal hypertension and the circadian blood pressure rhythm in patients with morbid obesity. Surgery. 2012 May;151(5):674-80. doi: 10.1016/j.surg.2011.12.007. Epub 2012 Jan 18.'}, {'pmid': '21943153', 'type': 'DERIVED', 'citation': 'Fredheim JM, Rollheim J, Omland T, Hofso D, Roislien J, Vegsgaard K, Hjelmesaeth J. Type 2 diabetes and pre-diabetes are associated with obstructive sleep apnea in extremely obese subjects: a cross-sectional study. Cardiovasc Diabetol. 2011 Sep 25;10:84. doi: 10.1186/1475-2840-10-84.'}, {'pmid': '21078684', 'type': 'DERIVED', 'citation': 'Hofso D, Jenssen T, Bollerslev J, Ueland T, Godang K, Stumvoll M, Sandbu R, Roislien J, Hjelmesaeth J. Beta cell function after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2011 Feb;164(2):231-8. doi: 10.1530/EJE-10-0804. Epub 2010 Nov 15.'}, {'pmid': '20798226', 'type': 'DERIVED', 'citation': 'Hofso D, Nordstrand N, Johnson LK, Karlsen TI, Hager H, Jenssen T, Bollerslev J, Godang K, Sandbu R, Roislien J, Hjelmesaeth J. Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2010 Nov;163(5):735-45. doi: 10.1530/EJE-10-0514. Epub 2010 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'This follow up study (\\>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.', 'detailedDescription': 'Not addressed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbidly obese patients\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00273104', 'briefTitle': 'The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital of Vestfold'}, 'officialTitle': 'The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities', 'orgStudyIdInfo': {'id': 'S-05175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bariatric surgery', 'description': 'Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.', 'interventionNames': ['Procedure: Bariatric surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive lifestyle intervention', 'description': 'Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.', 'interventionNames': ['Behavioral: Intensive lifestyle intervention']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.', 'armGroupLabels': ['Bariatric surgery']}, {'name': 'Intensive lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.', 'armGroupLabels': ['Intensive lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3117', 'city': 'Tønsberg', 'country': 'Norway', 'facility': 'Hospital in Vestfold', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}], 'overallOfficials': [{'name': 'Jøran Hjelmesæth, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Vestfold'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital of Vestfold', 'class': 'OTHER'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Morbid Obesity Centre', 'investigatorFullName': 'Jøran Hjelmesæth', 'investigatorAffiliation': 'The Hospital of Vestfold'}}}}