Last update : 07/07/2015 | Version : 2 | ID : 60158
| General | |
| Identification | |
| Detailed name | Foetal Growth, Metabolic Syndrome and Insulin Resistance |
| Sign or acronym | CASYMIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Nutrition |
| Keywords | Foetus, growth, anthropometry, metabolic status, hormonal status, nutritional status, birth |
| Scientific investigator(s) (Contact) | |
| Name of the director | Milanovic |
| Surname | Ivana |
| Name of the director | Levy-Marchal |
| Surname | Claire |
| Address | 75019 PARIS |
| Phone | +33 (0)1 40 03 19 92 |
| claire.levy-marchal@inserm.fr | |
| Unit | U690 |
| Organization | INSERM |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | PHRC National 2006 Pfizer international - Endocrie care |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| 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. | Prospective. Inclusion cut-off date: 01/12/2008. Number of required subjects: [100-500]. |
| Database objective | |
| Main objective | To investigate early growth phases (foetal growth, birth weight and postnatal growth) in relation to elements of metabolic syndrome and insulin resistance. Secondary objective: to investigate growth and body composition, metabolic and hormonal profiles from birth until 4 years of age with regard to birth weight and foetal growth velocity. |
| Inclusion criteria | Pregnancy with risk factor of low birth weight. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Predominantly in 3 centres throughout Île-de-France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2003 |
| Date of last collection (YYYY or MM/YYYY) | 12/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 580 femmes/women239 enfants/children |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Metabolic profile and fasting hormone |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Others |
| Details of biobank content | Serum bank, placenta |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Clinical examinations: handwritten Biological analysis: direct input. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Every 4 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-CASYMIR |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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