{"study_desc":{"title_statement":{"idno":"FRESH-PEF5682-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5682"},{"agency":"FReSH","code":"FRESH-PEF5682"}]},"title":"Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)","alternate_title":"ABOS (Atlas Biologique de l'Ob\u00e9sit\u00e9 S\u00e9v\u00e8re)"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"Fran\u00e7ois;PATTOU","firstname":"Fran\u00e7ois","lastname":"PATTOU","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"uri":"0000-0001-8388-3766","role":"pi id","title":"ORCID"},{"uri":"074750364","role":"pi id","title":"IdRef"}],"email":"fpattou@univ-lille2.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","PILabo":"CHRU \/ INSERM U859","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04"},{"title":"SIREN","uri":"265906719"}]},{"name":"VAIOMER","extlink":[{"title":"SIREN","uri":"530022888"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;PATTOU","lastname":"PATTOU","firstname":"Fran\u00e7ois","type":"contact","email":"fpattou@univ-lille2.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"diabetis"},{"keyword":"bariatric surgery"},{"keyword":"obesity"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"D004704"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"The objective of this trial is to study the influence of phenotypic characteristics on gene expression of tissues involved in glucose or\/and lipidic metabolism with the creation of a collection of biological samples for research on obesity and diabetes.","abstract":"","coll_dates":[{"start":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Child (6 to 12 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}}],\"level_type_clusion_I\":\"General population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"\u2022 Age between 18 and 65 years. \u2022 Indication of abdominal surgery requiring laparotomy or coelioscopy for obesity surgery, a cholecystectomy, or a parietal surgery. \u2022 phenotype corresponding to one of the following four cases 1. BMI greater than or equal to 35 kg\/m2 and diabetes defined by glucose greater or equal to 7 mmol\/l fasting and\/or greater than or equal to 11.1 mmol\/l, 120 min after glucose intake (OGTT). 2. BMI greater than or equal to 35 kg\/m2 and IGT defined by a higher than 6 mmol\/l and less than 7 mmol\/l fasting blood glucose, and\/or greater than 7.8 mmol\/l and less than 11.1 mmol\/l, 120 min after glucose intake (OGTT). 3. BMI greater than or equal to 35 kg\/m2 and with normal glucose tolerance defined by a blood glucose of less than or equal to 6 mmol\/l and\/or less than or equal to 7.8 mmol\/l, 120 min after glucose intake (OGTT). 4. BMI inferior to 27 kg\/m2 and with normal glucose tolerance defined by a blood glucose of less than or equal to 6 mmol\/l and\/or less than or equal to 7.8 mmol\/l, 120 min after glucose intake (OGTT) (control group). 5. BMI between 27 and 35 27 kg\/m2 and with normal glucose tolerance defined by a blood glucose less than or equal to 6 mmol\/l and\/or less than or equal to 7.8 mmol\/l, 120 min after glucose intake (OGTT) (control group).\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['monitoring promoteur']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"850"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"26-03-2013","lastUpdatedManual":"17-11-2014","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-ABOS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industry","Public (Europe)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"before and after bariatric surgery","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Prospective assessment of clinical features before and after bariatric surgery: weight, BMI, blood pressure","biologicalDataDetails":"Prospective assessment of biological features before and after bariatric surgery: alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose, fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}