{"doc_desc":{"title":"Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)","idno":"FRESH-PEF5682-en","producers":[{"name":"Fran\u00e7ois PATTOU","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)"}]},"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":[]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;PATTOU","PILabo":"CHRU \/ INSERM U859","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0001-8388-3766","role":"pi id"},{"title":"IdRef","uri":"074750364","role":"pi 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(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":"http:\/\/id.nlm.nih.gov\/mesh\/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":"{\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\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"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).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological 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\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","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":"26-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"17-11-2014","isContributorPI":"No","contributorName":"Fran\u00e7ois PATTOU","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","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":"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":"before and after bariatric surgery","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"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":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}