ITMO public health
Last update : 07/06/2015 | Version : 1 | ID : 5287
| General | |
| Identification | |
| Detailed name | Cohort of Patients Fulfilling at Least One Metabolic Syndrome Criterion |
| Sign or acronym | METABOL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. : 117 48 22 (MR001/08/06/2006); AFFSAPS : no. 2009-A00857-50 (24/09/2009); CPP Ouest II : no. 2009-18 (01/12/2009) |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Nutrition |
| Keywords | factor, prospective, complication, relationship, assessment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ramaroson |
| Surname | Andriantsitohaina |
| Address | IBS Institut de Biologie en Santé Allée du Pont CHU d’Angers 4 rue Larrey 49933 Angers Cedex 9 |
| Phone | +33 (0)2 44 68 85 80 |
| ramaroson.andriantsitohaina@univ-angers.fr | |
| Unit | INSERM U1063 - Stress Oxydant et Pathologies Métaboliques |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Boursier |
| Surname | Jérôme |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | 2008 Pays-de Loire Regional Call for Projects. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| 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 |
No |
| Additional information regarding sample selection. | Active patient population undergoing metabolic and vascular assessment at the Cross-Sectional Nutrition Unit of Angers UHC. The active patient population consists of consecutive subjects admitted as outpatients and fulfilling at least one metabolic syndrome criterion. |
| Database objective | |
| Main objective |
Main aim: to prospectively assess the role of hepatic steatosis in the onset of a metabolic syndrome (MS) and disorders linked to the kidney disease/MS combination
Secondary objectives: - To measure the chief complication of hepatic steatosis, i.e. liver fibrosis; and to study the connection to MS, non-alcoholic fatty liver disease (NAFLD) and sleep apneoa syndrome (SAS). - To determine whether blood tests established for the non-invasive diagnosis of liver damage (steatosis, inflammation, liver fibrosis) in dysmetabolic liver disease also have prognostic value and may identify patients at risk of cardiovascular complications, malignancies, diabetes, or SAS. |
| Inclusion criteria | Patients aged between 18 and 65 years old, with non-alcoholic fatty liver disease (NAFLD) and/or diabetes and/or sleep apnoea. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | 3 departments in Angers UHC (Endocrinology-Nutrition, Gastroenterology and Pulmonology). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 237 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data collected by the CRA recruited for the project at the time of outpatient hospitalisation. The CRA enters the data in a secure file (Epidata) that belongs to the hospital’s clinical research centre. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up visit every 3 years for 12 years. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Publications.
The epidata is transferred to Excel and checked by our data manager at the hospital's clinical research center. Access is limited to members of the METABOL cohort scientific committee. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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