Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT01112228
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Staging Tools for the Impacts of Obesity on Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.leroux@imperial.ac.uk', 'phone': '07970719453', 'title': 'Carel le Roux', 'organization': 'Imperial College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'As per usual', 'eventGroups': [{'id': 'EG000', 'title': 'Obese Patients', 'description': 'Obese patients for Bariatric surgery\n\nBariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding', 'otherNumAtRisk': 600, 'deathsNumAtRisk': 600, 'otherNumAffected': 30, 'seriousNumAtRisk': 600, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Obesity Scores After Weight Loss Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Patients', 'description': 'Obese patients for Bariatric surgery\n\nBariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding'}], 'classes': [{'categories': [{'measurements': [{'value': '600', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Minimum of 1 year follow-up', 'description': 'Changes were measured in the following clinical domains\n\n-Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image.\n\nAn improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed.\n\nOut measure is calculated as the count of participants achieving at least 1 improvement (Count)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Obese patients for Bariatric surgery'}, {'type': 'SECONDARY', 'title': 'Changes in Obesity Scores in Various Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes and Obesity', 'description': "Patients with diabetes pre-surgery who had improvement in any one of the clinical domains as measure in the King's Obesity Staging Score"}, {'id': 'OG001', 'title': 'Patients With Sleep Apnea', 'description': "Patients with Sleep Apnea pre-surgery who had improvement in any one of the clinical domains as measured in the King's Obesity Staging Score"}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Minimum of 1 year follow-up', 'description': 'Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obese Patients', 'description': 'Obese patients for Bariatric surgery\n\nBariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Obese Patients', 'description': 'Obese patients for Bariatric surgery\n\nBariatric surgery: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '48', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '420', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '600', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (kg/m2 )', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2010-04-26', 'resultsFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Obesity Scores After Weight Loss Treatment', 'timeFrame': 'Minimum of 1 year follow-up', 'description': 'Changes were measured in the following clinical domains\n\n-Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image.\n\nAn improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed.\n\nOut measure is calculated as the count of participants achieving at least 1 improvement (Count)'}], 'secondaryOutcomes': [{'measure': 'Changes in Obesity Scores in Various Subgroups', 'timeFrame': 'Minimum of 1 year follow-up', 'description': 'Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '25585572', 'type': 'DERIVED', 'citation': 'Aasheim ET, Aylwin SJ, Radhakrishnan ST, Sood AS, Jovanovic A, Olbers T, le Roux CW. Assessment of obesity beyond body mass index to determine benefit of treatment. Clin Obes. 2011 Apr;1(2-3):77-84. doi: 10.1111/j.1758-8111.2011.00017.x. Epub 2011 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment.', 'detailedDescription': 'This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with BMI \\> 40 or \\>35 and a obesity-related medical condition', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obesity\n* At least 1 year follow-up after bariatric surgery\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01112228', 'acronym': 'COST', 'briefTitle': 'Clinical Staging Tools for the Impacts of Obesity on Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Assessing Clinical Staging Tools for Tracking the Impacts of Obesity on Individuals', 'orgStudyIdInfo': {'id': 'Clinical Obesity Staging Tools'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients', 'description': 'Obese patients for Bariatric surgery', 'interventionNames': ['Procedure: Bariatric surgery']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding', 'armGroupLabels': ['Obese patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial Weight Centre, Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Carek le Roux, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}