{"doc_desc":{"title":"Massive Obesity and Surgery: Referral Centre Cohort for Medical and Surgical Inpatient Treatment for Massive Obesity","idno":"FRESH-PEF60103-en","producers":[{"name":"Arnaud BASDEVANT","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60103-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60103"},{"agency":"FReSH","code":"FRESH-PEF60103"}]},"title":"Massive Obesity and Surgery: Referral Centre Cohort for Medical and Surgical Inpatient Treatment for Massive Obesity","alternate_title":"OBEMASCH"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Arnaud;BASDEVANT","PILabo":"APHP \/ INSERM U872 (EQUIPE 7) Centre de recherche en nutrition humaine Ile de FranceCentre de r\u00e9f\u00e9rence APHP pour la prise en charge m\u00e9dicale et chirurgicale de l'obesit\u00e9 CRMOPIERRE ET MARIE-CURIE-PARIS 6, HOPITAL PITIE-SALPETRIERE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"028587022","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Karine;CLEMENT","PILabo":"APHP \/ EQ 7 INSERM U 872 CR CORDELIERS CENTRE DE RECHERCHE EN NUTRITION HUMAINE ILE DE FRANCE INSERM UP6","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-2489-3355","role":"pi id"},{"title":"IdRef","uri":"052455718","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"karine.clement@aphp.fr","isContact":"Yes"}],"oth_id":[{"name":"Enrolment in a European project: HEPADIP AND ADAPT","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Karine;CLEMENT","email":"karine.clement@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"medical assessment"},{"keyword":"determinants"},{"keyword":"somatic"},{"keyword":"biological"},{"keyword":"psychological"},{"keyword":"metabolic"},{"keyword":"social"},{"keyword":"consequences"},{"keyword":"cardiovascular"},{"keyword":"respiratory"},{"keyword":"complications"},{"keyword":"deficiencies"},{"keyword":"oral dental condition"},{"keyword":"nutritional assessment"},{"keyword":"evaluation"},{"keyword":"health events"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"General objective: to monitor variations in weight and body composition as well as metabolic, cardiovascular and pulmonary comorbidities introduced by surgery for obesity. Secondary objective: to study tissue, vitamin, cellular and systemic physiopathological changes (metabolic and inflammatory phenomena, insulin resistance) induced by bariatric surgery.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients diagnosed as massively obese (BMI greater than 40 kg\\\/m\u00b2) or severely obese (BMI between 35-40 kg\\\/m\u00b2) with comorbidities (diabetes, sleep apnoea syndrome, arterial hypertension etc.) and whose weight is stable or has increased over a 3 month period (weight change of at least 2 kg) preceding gastric surgery (bypass, sleeves, ring), after a decision made by a multi-disciplinary team and medical follow-up for at least one year. Between 18 and 55 years of age.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Request for consistency after data is processed electronically. Missing data is managed by returning to source record or third party. Physicians contacted again for follow-up visits Subjects contacted again for follow-up visits Internal quality audits carried out once per month as part of the CRC An APHP audit was carried out in 2007 on the database from 2005 Other quality procedure(s): a systematic return and verification of source data is carried out by the researcher with contact from physician collecting the clinical and laboratory data during data analysis as part of the studies conducted by the INSERM team. Aberrant laboratory values are verified from source data Patients are informed of the use of their data']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"479 (depuis\/since 2002)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data may be used by academic teams. Data may be used by industrial teams.","conditions":"Access conditions for academic teams: several hospitals and research teams are interested in kinetic evolution of comorbidities using the bypass model; many specialities are involved and several collaborations are taking place, such as: - Bone characteristics study (bone remodelling factors) Dr. Richette&#x27;s rheumatology department hospital team, Lariboisiere - post- and pre-operative masticatory characteristics study (Bretonneau hospital, Dr. Miller) - intestinal flora study (Dr. Joel Dore and Dr. Corthier) or within the European programme framework (ADAPT, HEPADIP) All studies are subject to CPP (Ethics Committee) review and specific funding. Bioresource usage is subject to MTA (material transfer agreement) with APHP. Access conditions for industrial teams : Specific APHP or INSERM industry contracts A contract was established in 2006 with Berlin Metabomics to investigate metabolic evolution","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"22-07-2014","isContributorPI":"No","contributorName":"Karine CLEMENT","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: entry from paper questionnaire Clinical examinations: direct input Biological analysis: direct input","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Ile de France: a study on geographical origin of patient enrolment shows that 25% of patients come from central Paris. The other part mainly comes from the Paris Basin. The other portion mainly originates from the Paris Basin."},"dataTypes":{"clinicalDataDetails":"- Family history (obesity, diabetes, cardiovascular disease); - Personal weight history; - anthropometric parameters (weight, height, BMI, waist circumference, hip and neck measurements); - assessment of comorbidities (diabetes, dyslipidemia, cardiovascular, hypertension, respiratory, articular); - Oral and gastric assessment; - nutritional assessment; - treatment; - adverse events (surgical complications).","biologicalDataDetails":"Type of samples taken: usual tests (complete blood count, electrolytes, free fatty acids and glycerol, liver function test, lipid profile, fasting glycaemia, HbA1c, serum calcium, thyroid function, vitamin assessment, calcium-phosphate product, albumin, pre-albumin, orosomucoid, fibrinogen, iron status, zinc, selenium) corpus. Induced changes in levels of leptin, ghrelin, insulin, adiponectin, interleukin-6) DNA research (MC4R gene mutation). Urine sample (microalbuminuria, calcium-phosphate product). Adipose tissue celluarity and anatomical pathology (liver, adipose tissue).","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}