MELODIE - Elaboration of a predictive clinical score to evaluate the adherence of obese, type 2 diabetic patient to the physician's recommendations in terms of medications, exercise and diet 
Head :
Vignal Franck, Sanofi Aventis
Last update : 01/01/2018 | Version : 1 | ID : 91
| General | |
| Identification | |
| Detailed name | Elaboration of a predictive clinical score to evaluate the adherence of obese, type 2 diabetic patient to the physician's recommendations in terms of medications, exercise and diet |
| Sign or acronym | MELODIE |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Others (details) | type-2 diabetes, obesity |
| Keywords | predictive score, adhesion to the modifications in the therapeutic care of their life hygiene |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vignal |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | each doctor accepting to participate in the study had to respectively include the first 5 consecutive patients seen in consultation and who correspond to the selection criteria |
| Database objective | |
| Main objective | Using the cardiovascular risk factors of unbalanced obese type-2 diabetes patients, develop a clinical predictive score of the adhesion of patients to the modifications in their therapeutic care and/or in their life hygiene that are prescribed for them |
| Inclusion criteria | Man or woman over the age of 18 years; Type-2 diabetes treated via oral diabetes medication monotherapy; HbA1c ≥ 6.5%; BMI ≥ 30 kg/m2; Abdominal obesity defined according to the NCEP/ATPIII – 2001 criteria: waist > 88 cm for women and > 102 cm for men. |
| 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 |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5040 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | type-2 diabetes, adhesion to the modifications in the therapeutic care of their life hygiene |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
