ITMO public health
Last update : 07/23/2015 | Version : 2 | ID : 5682
| General | |
| Identification | |
| Detailed name | Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection) |
| Sign or acronym | ABOS (Atlas Biologique de l'Obésité Sévère) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP 06/49, DGS 2006/0307 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Genetic Nutrition |
| Keywords | diabetis, bariatric surgery, obesity |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pattou |
| Surname | François |
| Address | 1 Place Verdun |
| Phone | + 33 (0)3 20 44 42 73 |
| fpattou@univ-lille2.fr | |
| Unit | INSERM U859 |
| Organization | CHRU |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Programme IT-DiabProgramme IMI-DIRECT |
| Funding | |
| Funding status |
Mixed |
| Details | CHRU LilleVaiomerIMI - Innovative Medicines Initiative / DIRECT - Diabetes Research on Patient Stratification |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHRU Lille |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. | Liver samples before and at 1 and 5 years after bariatric surgeryMuscle samples before and at 1 year after bariatric surgerySubcutaneous fat samples before and at 3 month and 1 year after bariatric surgeryVisceral fat samples in the great omentum before bariatric surgeryIntestinal samples during gastric by-pass surgeryBlood samples baseline and at at 1, 3 months, 1, 2, 5 years after surgery |
| Database objective | |
| Main objective | 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. |
| Inclusion criteria |
• Age between 18 and 65 years.
• Indication of abdominal surgery requiring laparotomy or coelioscopy for obesity surgery, a cholecystectomy, or a parietal surgery. • 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). |
| Population type | |
| Age |
Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 850 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Prospective assessment of clinical features before and after bariatric surgery: weight, BMI, blood pressure |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Details of collected declarative data | Prospective assessment of clinical features before and after bariatric surgery: weight, BMI, blood pressure |
| Biological data (detail) | 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) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Blood cells isolated Tissues DNA |
| Details of biobank content | Liver samples before and at 1 and 5 years after bariatric surgeryMuscle samples before and at 1 year after bariatric surgerySubcutaneous fat samples before and at 3 month and 1 year after bariatric surgeryVisceral fat samples in the great omentum before bariatric surgeryIntestinal samples during gastric by-pass surgeryBlood samples baseline and at at 1, 3 months, 1, 2, 5 years after surgery |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | before and after bariatric surgery |
| Quality procedure(s) used | monitoring promoteur |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Prospective assessment of clinical and biological features before and after bariatric surgeryLiver samples before and at 1 and 5 years after bariatric surgeryMuscle samples before and at 1 year after bariatric surgerySubcutaneous fat samples before and at 3 month and 1 year after bariatric surgeryVisceral fat samples in the great omentum before bariatric surgeryIntestinal samples during gastric by-pass surgeryBlood samples baseline and at at 1, 3 months, 1, 2, 5 years after surgery |
| Links to administrative sources |
Yes |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-ABOS |
| Description | Liste des publications dans HAL |
| Link to the document | http://tinyurl.com/Pubmed-ABOS |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the investigator |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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