Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00289705
Status:
UNKNOWN
Last Update Posted:
2017-02-02
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Intervention for Morbidly Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI development', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Surgery', 'Adolescent', 'Roux-en-Y gastric bypass', 'Laparoscopic'], 'conditions': ['Obesity', 'Diabetes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '33079376', 'type': 'DERIVED', 'citation': 'Jarvholm K, Olbers T, Peltonen M, Marcus C, Flodmark CE, Gronowitz E, Dahlgren J, Karlsson J. Depression, anxiety, and suicidal ideation in young adults 5 years after undergoing bariatric surgery as adolescents. Eat Weight Disord. 2021 May;26(4):1211-1221. doi: 10.1007/s40519-020-01024-0. Epub 2020 Oct 20.'}, {'pmid': '31978372', 'type': 'DERIVED', 'citation': 'Jarvholm K, Bruze G, Peltonen M, Marcus C, Flodmark CE, Henfridsson P, Beamish AJ, Gronowitz E, Dahlgren J, Karlsson J, Olbers T. 5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study. Lancet Child Adolesc Health. 2020 Mar;4(3):210-219. doi: 10.1016/S2352-4642(20)30024-9. Epub 2020 Jan 21.'}, {'pmid': '28065734', 'type': 'DERIVED', 'citation': 'Olbers T, Beamish AJ, Gronowitz E, Flodmark CE, Dahlgren J, Bruze G, Ekbom K, Friberg P, Gothberg G, Jarvholm K, Karlsson J, Marild S, Neovius M, Peltonen M, Marcus C. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017 Mar;5(3):174-183. doi: 10.1016/S2213-8587(16)30424-7. Epub 2017 Jan 6.'}, {'pmid': '27071497', 'type': 'DERIVED', 'citation': 'Beamish AJ, Gronowitz E, Olbers T, Flodmark CE, Marcus C, Dahlgren J. Body composition and bone health in adolescents after Roux-en-Y gastric bypass for severe obesity. Pediatr Obes. 2017 Jun;12(3):239-246. doi: 10.1111/ijpo.12134. Epub 2016 Apr 12.'}, {'pmid': '24491362', 'type': 'DERIVED', 'citation': 'Gothberg G, Gronowitz E, Flodmark CE, Dahlgren J, Ekbom K, Marild S, Marcus C, Olbers T. Laparoscopic Roux-en-Y gastric bypass in adolescents with morbid obesity--surgical aspects and clinical outcome. Semin Pediatr Surg. 2014 Feb;23(1):11-6. doi: 10.1053/j.sempedsurg.2013.10.015. Epub 2013 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.\n\nOur hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.', 'detailedDescription': 'Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI \\>40kg/m2 in the adolescence will remain morbidly obese also in their adult life.\n\nThe three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.\n\nSubjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>40 kg/m2 or BMI\\>35 with comorbidity\n* Pass psychological evaluation\n* Puberty status Tanner 4-5\n* At least one year with active conservative treatment that failed\n\nExclusion Criteria:\n\n* Lack of compliance\n* Specific obesity syndrome as Praeder Willis\n* Obesity due to brain injury\n* Severe general disease\n* Specific genetic defect (MC4R, Leptin deficiency)'}, 'identificationModule': {'nctId': 'NCT00289705', 'briefTitle': 'Surgical Intervention for Morbidly Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study', 'orgStudyIdInfo': {'id': 'SU523-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery', 'description': 'Laparoscopic gastric bypass', 'interventionNames': ['Procedure: Surgery']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Traditional treatment for obesity'}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic Roux-en-Y gastric bypass', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'state': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital, Dept of Surgery', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'state': 'Göteborg', 'country': 'Sweden', 'facility': 'Queen Silvias Children Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Malmo', 'state': 'Malmö', 'country': 'Sweden', 'facility': 'Dept of Pediatrics, MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '14186', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'National center for child obesity, Karolinska Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Torsten Olbers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}, {'name': 'Clude Marcus, Prof, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept of Pediatrics, Karolinska University Hospital, Huddinge'}, {'name': 'Staffan Mårild, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Queen Silvias Childs Hospital, Gothenburg'}, {'name': 'Carl-Erik Flodmark, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept of Pediatrics, MAS, Malmö'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}