Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT02378259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-03-25
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
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'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 2333635, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-01T05:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomisation between Bariatric surgery (mainly Roux-en-Y gastric bypass) or Intensive Medical treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2034-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cancer or precancerous lesions', 'timeFrame': '15 years after treatment initiation and later', 'description': 'As this parameter is hard to foresee we might need to extend the time for assessment longer than 15 years'}], 'primaryOutcomes': [{'measure': 'Body Mass Index (kg/m2)', 'timeFrame': '2 years after treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Metabolic control', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Glucose control (fP-Glc, fs-Insulin, HbA1c, Oral glucose tolerance test), Blood lipids (HDL, LDL, TG, Apo A, Apo B), Blood pressure (systolic and diastolic), Inflammation (LPK, CRP, Adiponectin, IL-6, TNF-alfa), liver function tests (AST, ALT, ALP, Bil)'}, {'measure': 'Quality of life, generic', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Mental and physical quality of life assessed by Short Form-36 (score 0-100, lower= more disability)'}, {'measure': 'Obesity-specific quality of life', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Obesity Problem scale- 9 items (score 0-100, higher score= more psychosocial impairment)'}, {'measure': 'Socioeconomic development', 'timeFrame': '5, 10 and 15 years after treatment initiation', 'description': 'Education, civil status, number of children, income, sick leave (from national registries)'}, {'measure': 'Health care consumption', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'In hospital care, outpatient care, prescribed medications; from national registries'}, {'measure': 'Skeletal maturation and quality', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Bone mineral content and bone mineral density will be assessed as well as blood markers for bone formation and resorption'}, {'measure': 'Addictive behavior', 'timeFrame': '2, 5, 10, 15 years after treatment initiation', 'description': 'Alcohol consumption, blood markers for alcohol consumption, drugs, brain response to visual stimuli'}, {'measure': 'Mental health', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Depression, anxiety, self esteem, stability in neuropsychiatric disease (ADHD, ADD), psychiatric illness, OCD'}, {'measure': 'Adverse events', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Any adverse event (physical, mental or other)'}, {'measure': 'Eating function', 'timeFrame': '2, 5, 10 and 15 years after treatment initiation', 'description': 'Assessment of meal pattern, dietary composition and gastrointestinal symptoms in relation to eating'}, {'measure': 'Energy expenditure', 'timeFrame': '5 years after treatment initiation', 'description': 'Doubly labelled water, basic metabolic rate, 24h energy expenditure chamber 5 years'}, {'measure': 'Body Mass Index, body weight, height. Additional assessments of primary outcome', 'timeFrame': '5, 10 and 15 years after treatment initiation', 'description': 'Weight (kg) and height (m) will be combined to report BMI in kg/m2'}, {'measure': 'Cognitive Function', 'timeFrame': '1, 2 and 5 years after treatment initiation', 'description': 'General cognitive functioning (IQ test- WISC-IV Wechsler Intelligence Scale for Children) Scale 1-200 where lower score means worse)'}, {'measure': 'Working memory', 'timeFrame': '1, 2 and 5 years after treatment initiation', 'description': 'Memory (D-KEFS-Delis-Kaplan Executive Function System) several subscales 0-15, lower value means worse'}, {'measure': 'Attention', 'timeFrame': '1, 2 and 5 years after treatment initiation', 'description': 'Attention (NEPSY- NEuroPSYcologic examination). Separate subscales for executive function and attention, language, memory and learning, sensorimotor, visuospatial processing, and social perception. Lower value means worse.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Diabetes', 'Hypertension', 'Steatohepatitis', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '38685922', 'type': 'DERIVED', 'citation': 'Jarvholm K, Gronowitz E, Janson A, Peltonen M, Sjogren L, Beamish AJ, Dahlgren J, Martensson J, Olbers T. Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial. EClinicalMedicine. 2024 Feb 27;70:102505. doi: 10.1016/j.eclinm.2024.102505. eCollection 2024 Apr.'}, {'pmid': '36848922', 'type': 'DERIVED', 'citation': 'Jarvholm K, Janson A, Peltonen M, Neovius M, Gronowitz E, Engstrom M, Laurenius A, Beamish AJ, Dahlgren J, Sjogren L, Olbers T. Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden. Lancet Child Adolesc Health. 2023 Apr;7(4):249-260. doi: 10.1016/S2352-4642(22)00373-X. Epub 2023 Feb 24.'}, {'pmid': '32637723', 'type': 'DERIVED', 'citation': 'Janson A, Jarvholm K, Gronowitz E, Sjogren L, Klaesson S, Engstrom M, Peltonen M, Ekbom K, Dahlgren J, Olbers T. A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13-16 years (AMOS2): Rationale, study design, and patient recruitment. Contemp Clin Trials Commun. 2020 Jun 27;19:100592. doi: 10.1016/j.conctc.2020.100592. eCollection 2020 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes.\n\nThis is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.', 'detailedDescription': 'A multicentre randomised clinical trial where three tertiary referral hospitals recruit patients.\n\nPatients and their parents receive information about the study at their paediatric clinic and at the trial web page (www.amos2.se). Standardised procedure, including signed informed consent.\n\nInterventions\n\nAt the end of day of baseline examination patients are randomised to either of two arms:\n\n* Bariatric surgery with regular follow up\n* Optimised conservative treatment starting with an 8-week Low Calorie Diet period followed by tailored support and treatment by the multidisciplinary team with an intensity of at least one visits a month over at least 2 years\n\nPatients in the conservative arm will be reassessed regarding interest of undergoing bariatric surgery two years after inclusion.\n\nSample Size A sample size of 50 (25+25) leaves a power of more than 95% to evaluate a possible superiority of \\>10% weight difference between the two groups, assuming a 15% standard deviation in weight loss over follow-up at 2.5% significance level.\n\nThis number also allows assessment for differences in cardiovascular risk factors with sufficient power and acceptable power for demonstrating differences in quality of life and cognitive functions.\n\n3.6 Randomization The computerized random allocation is performed during the day of baseline examination and patients were informed of their assignment. Forty-nine patients have been included until May 2017, and the last patient will be operated on June 14th. Stratification has been performed according to the recruitment centre\n\n3.8 Statistical Methods \\& Additional Analyses Safety \\& Efficacy Outcomes: Analyses will be by intention to treat, including all randomised patients. Difference in treatment effect will be evaluated with hazard ratio between the treatment groups, and the corresponding confidence interval will be calculated. For secondary outcomes, the incidence of comorbidities during follow-up will be evaluated using time-to-event models, and for continuous variables mixed models will be used to evaluate differences between the treatment groups.\n\nIncremental cost-effectiveness analysis will be conducted by calculating the incremental cost-effectiveness ratio (ICER; dividing the between-group difference in costs with the between-group difference in quality-adjusted life-years (QALYs) as well as life-years). Probabilistic sensitivity analysis will be conducted and results presented in an ICER scatterplot and cost-effectiveness acceptability curve.\n\nFollow-Up Clinical Data Collection: Study point are 6 weeks, 1 year, 2 years, and 5 years after the start of intervention. Weight, quality of life, and adverse events, as well as clinical data regarding treatments for co-morbidities. Blood sampling for assessment of nutritional deficiencies, glucose control, blood lipids and inflammation will be collected at baseline and 1, 2 and 5 years.\n\nCognitive functions: Assessments will be performed at baseline and 1 and 2 years after start of intervention.\n\nRegister-Based Data Collection and Health-Economic Outcomes: Collection and analysis of Swedish national health care and other official registries\n\nWe decided in the Study Steering Committee to change time points for long term follow up to be 5, 10 and 15 years after treatment initiation to better comply with standard schedules for clinical follow up in registers (instead of 7, 12 and 17y after treatment initiation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-16 years\n* BMI \\>35\n* Failed comprehensive treatment for obesity \\> 1 year\n* Passing assessment of psychologist\n* Tanner 3 or more\n\nExclusion Criteria:\n\n* Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl)\n* Obesity secondary to brain injury\n* Severely mentally disabled\n* Not eligible for general anesthesia\n* Psychotic or other major psychiatric illness\n* Previous major gastrointestinal surgery'}, 'identificationModule': {'nctId': 'NCT02378259', 'acronym': 'AMOS2', 'briefTitle': 'Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'AMOS2 (Adolescent Morbid Obesity Surgery)', 'orgStudyIdInfo': {'id': '578-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bariatric surgery', 'description': 'Roux-en-Y gastric bypass surgery', 'interventionNames': ['Procedure: Laparoscopic Roux-en-Y gastric bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intense conservative treatment', 'description': 'Intense conservative treatment. 8 week LCD followed by outpatient visits 1/ month', 'interventionNames': ['Procedure: Intense conservative treatment']}], 'interventions': [{'name': 'Laparoscopic Roux-en-Y gastric bypass', 'type': 'PROCEDURE', 'description': 'Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy', 'armGroupLabels': ['Bariatric surgery']}, {'name': 'Intense conservative treatment', 'type': 'PROCEDURE', 'description': 'Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years', 'armGroupLabels': ['Intense conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Torsten Olbers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Gothenburg, Dept of Surgical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}