METABOL - Cohort of Patients Fulfilling at Least One Metabolic Syndrome Criterion

Head :
Ramaroson Andriantsitohaina, INSERM U1063 - Stress Oxydant et Pathologies Métaboliques
Boursier Jérôme

Last update : 07/06/2015 | Version : 1 | ID : 5287

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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