Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT00239850
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight reduction'}, {'measure': 'quality of life'}], 'secondaryOutcomes': [{'measure': 'reduction in obesity complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'lifestyle', 'treatment', 'Complications', 'endocrine changes', 'Lipids', 'C18.654.726.500.495'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '20379796', 'type': 'RESULT', 'citation': 'Martins C, Strommen M, Stavne OA, Nossum R, Marvik R, Kulseng B. Bariatric surgery versus lifestyle interventions for morbid obesity--changes in body weight, risk factors and comorbidities at 1 year. Obes Surg. 2011 Jul;21(7):841-9. doi: 10.1007/s11695-010-0131-1.'}, {'pmid': '28320081', 'type': 'RESULT', 'citation': 'Ovrebo B, Strommen M, Kulseng B, Martins C. Bariatric surgery versus lifestyle interventions for severe obesity: 5-year changes in body weight, risk factors and comorbidities. Clin Obes. 2017 Jun;7(3):183-190. doi: 10.1111/cob.12190. Epub 2017 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).', 'detailedDescription': 'The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. Sixty patients will participate in each group. Behavioural changes and weight loss over 4-5 years will be followed. We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) \\> 40 or BMI \\> 35 with complications\n\nExclusion Criteria:\n\n* Unstable atherosclerotic disease\n* Psychologically unstable\n* Unable to participate in the training program'}, 'identificationModule': {'nctId': 'NCT00239850', 'briefTitle': 'Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': '4.2005.33'}, 'secondaryIdInfos': [{'id': 'NSD12820', 'type': 'OTHER', 'domain': 'NSD'}, {'id': '05/3344TSP', 'type': 'OTHER', 'domain': 'TSP'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lifestyle changes', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7011', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Baard Kulseng, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital, Trondheim'}, {'name': 'Ronald Mårvik, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital, Trondheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}