ITMO public health
Last update : 08/06/2015 | Version : 3 | ID : 60103
| General | |
| Identification | |
| Detailed name | Massive Obesity and Surgery: Referral Centre Cohort for Medical and Surgical Inpatient Treatment for Massive Obesity |
| Sign or acronym | OBEMASCH |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 27/03/2007 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Genetic Iatrogenic Nutrition |
| Keywords | medical assessment, determinants, somatic, biological, psychological, metabolic, social, consequences, cardiovascular, respiratory, complications, deficiencies, oral dental condition, nutritional assessment, evaluation, health events |
| Scientific investigator(s) (Contact) | |
| Name of the director | Basdevant |
| Surname | Arnaud |
| Address | 75013 PARIS |
| Phone | + 33 (0)1 42 17 77 17 |
| arnaud.basdevant@psl.aphp.fr | |
| Unit | INSERM U872 (EQUIPE 7) Centre de recherche en nutrition humaine Ile de FranceCentre de référence APHP pour la prise en charge médicale et chirurgicale de l'obesité CRMOPIERRE ET MARIE-CURIE-PARIS 6, HOPITAL PITIE-SALPETRIERE |
| Organization | APHP |
| Name of the director | Clément |
| Surname | Karine |
| karine.clement@psl.aphp.fr | |
| Unit | EQ 7 INSERM U 872 CR CORDELIERS CENTRE DE RECHERCHE EN NUTRITION HUMAINE ILE DE FRANCE INSERM UP6 |
| Organization | APHP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Enrolment in a European project: HEPADIP AND ADAPT |
| Others | Other associated cohorts: current discussions with European teams (Switzerland, Italy, Sweden) involved in this type of surgery and patient monitoring. |
| Funding | |
| Funding status |
Mixed |
| Details | Resources are mainly public. However, private input was obtained on an ad hoc basis as part of the programme on changes in metabolism - APHP (DRC) - Ile de France Human Nutrition Research Centre (CRNH) - ALFEDIAM/AFERO - ANR - Inserm/UPMC (PROVISIONS) - METABOMICS (BERLIN, GERMANY) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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. | Prospective |
| Database objective | |
| Main objective | 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. |
| Inclusion criteria | Patients diagnosed as massively obese (BMI greater than 40 kg/m²) or severely obese (BMI between 35-40 kg/m²) 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. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | 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. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2002 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 479 (depuis/since 2002) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | - 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). |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Self-administered questionnaire at follow-up (TO, T3, T6 T12) Information collected by self-administered questionnaire: - Quality of life (SF 36 - Physical activity (Baecke) - alcohol and tobacco consumption, eating behaviour (TFEQ) - fatigue score and depression scale (Beck) - Epworth Scale (sleepiness), pain - Sandvik score (urinary incontinence) Interview questionnaire at baseline and during follow-up (TO, T3, T6, T12, every year) Information collected during interview: - socioeconomic status - dietary assessment (qualitative and quantitative input) - psychological assessment - clinical assessment - comorbidity assessment |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | 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). |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Tissues DNA |
| Details of biobank content | Serum bank, Plasma bank, DNA bank, adipose, liver, intestine and muscle tissue |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from paper questionnaire Clinical examinations: direct input Biological analysis: direct input |
| Quality procedure(s) used | 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 |
| Participant monitoring |
Yes |
| Details on monitoring of participants | before surgery, 1 month, 3 months, 6 months, 1 year and then every year during clinical assessment |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI, Pathology register |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access conditions: 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'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 Data may be used by industrial teams Access conditions: Specific APHP or INSERM industry contracts A contract was established in 2006 with Berlin Metabomics to investigate metabolic evolution |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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