EGIR-RISC - Relationship between insulin sensitivity and cardiovascular disease 
Head :
Balkau Beverley
Ferrannini Ele
Ferrannini Ele
Last update : 09/05/2017 | Version : 2 | ID : 3301
| General | |
| Identification | |
| Detailed name | Relationship between insulin sensitivity and cardiovascular disease |
| Sign or acronym | EGIR-RISC |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Addictions Social and psychosocial factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Balkau |
| Surname | Beverley |
| Phone | 0145595161 |
| beverley.balkau@inserm.fr | |
| Organization | Inserm |
| Name of the director | Ferrannini |
| Surname | Ele |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Financement européen public, AstraZeneca, Merck |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre de Recherche en Nutrition Humaine de Lyon (CRNHL) |
| 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 |
| Database objective | |
| Main objective |
Main objective: study of insulin resistance and atherosclerosis, determinants of insulin resistance, its evolution on 9 years and consequences, diabetes, cardiovascular diseases and premature death.
Secondary objectives: 1. The evaluation of insulin resistance and its association with cardiovascular diseases 2. Identification of genetic and environmental factors linked to insulin resistance 3. The proposition of a model to identify insulin resistance |
| Inclusion criteria |
- Aged between 30 and 60 years
- Good general health condition - No symptoms of cardiovascular diseases - blood pressure inferior to 170/90 mm Hg - Total cholesterol inferior to 7,8 mmol/l - Triglycerides levels inferior to 4,6 mmol/l - Plasma glucose level (on an empty stomach and 2 hours after an oral glucose control) inferior to 7,0/11,1 mmol/l - No treatment related to diabetes, hypertension or lipid disorders |
| Population type | |
| Age |
Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | Austria, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Italy, Sweden, Spain, Switzerland, United Kingdom, Serbia and Montenegro |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2002 |
| Date of last collection (YYYY or MM/YYYY) | 2007 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Phone interview |
| Paraclinical data (detail) | Imaging at inclusion and at 3 years : carotid artery scan, Doppler of arm arteries, full body scan in 2 centers (about 150 subjects) |
| Biological data (detail) | Plasma, serum, leukocyte layer, DNA |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Fluids (saliva, urine, amniotic fluid, …) DNA |
| Details of biobank content | At inclusion and at 3 years : blood (lipid profile, genetic characteristics analysis), urine |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview questionnaire : (1)Life habits, family history (2) occurrence of diseases (3) Lifestyle (personal and family history, tobacco, alcohol, peripheral arterial disease, angina (4) clinical signs or symptoms, diabetes ro weight variation since the examinations (5) Clinical signs or symptoms of cardiovascular diseases, diabetes or weight variation since the examinations, sleep and depression. Clinical examination : (6) Anthropometric measures, blood pressure, ECB, "body-fat" measure by biometrical impedance analysis, hyperinsulinemic-euglycemic clamp, glucose tolerance test, glucose test IV, quantity and quality evaluation of physical activity (7) Anthropometric measures, blood pressure, ECB, "body-fat" measure by biometrical impedance analysis, glucose tolerance test, glucose test IV |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up questionnaire |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/RISC_STUDY |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Balkau[Author]%29+AND+%28Risc+OR+%22Risk+study%22%29+OR+20660046[uid] |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | For data access, please submit a written request to the "project management board". Diffusion : oral communications during congresses, published articles, press releases, diffusion to general practitioners and diabetologists, newspapers |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
