ITMO public health
Last update : 01/22/2019 | Version : 2 | ID : 3956
| General | |
| Identification | |
| Detailed name | Genetic Polymorphism in Subjects with Type 2 Diabetes and Diabetic Nephropathy: Study “DIAB’2-NEPHRO-GENE” (DIABète de type 2, NEPHROpathie et GENEtique) |
| Sign or acronym | D2NG |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Méthodologie de référence MR-001 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Urology, andrology and nephrology |
| Health determinants |
Genetic Medicine Nutrition |
| Scientific investigator(s) (Contact) | |
| Name of the director | Hadjadj |
| Surname | Samy |
| Address | Centre d'investigation Clinique- Inserm CIC1402 ; 5 cour Est Jean Bernard ; BP 577 ; 86021 Poitiers Cedex |
| Phone | + 33 (0)5 49 44 46 89 |
| samy.hadjadj@gmail.com | |
| Unit | CIC 1402 |
| Organization | CHU Poitiers |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | PHRC interégionalAFD Recherche 2003ALFEDIAM 2009Association GEMMS Poitiers 2001-2012 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Poitiers |
| Organisation status |
Public |
| Additional contact | |
| Name of the contact | Michele |
| Surname | Grosdenier |
| Address |
Biobank CHU Poitiers 86021 Poitiers Cedex France |
| Phone | +33549444689 |
| michele.grosdenier.bruneau@chu-poitiers.fr | |
| Unit | Biobank |
| Organization | CHU Poitiers |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control 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. | Selection from active patient consultation files in different recruitment centres. |
| Database objective | |
| Main objective | MAIN: to study the genetic determinants associated with renal complications from Type 2 diabetes using a triple-integrated approach: *Association Study *Cross-population Study *Liaison Study SECONDARY: 1 - to investigate diabetic nephropathy specific phenotypes (anatomopathological criteria) 2 - to complete case-control analysis with a longitudinal follow-up study (SURDIAGENE project) |
| Inclusion criteria | Individuals included in the study are adult subjects who have given their signed informed consent and covered by a social security scheme or registered with a likewise scheme. We wish to include different subjects with type 2 diabetes in the DIAB2-NEPHRO-GENE study that can be divided into three groups: 1 - Case-control subjects (with no diabetic nephropathy) - subjects with diabetic retinopathy, regardless of stage - known type 2 diabetes for more than 5 years - normal urinary albumin excretion (UAE) (defined as urinary albumin concentration strictly below 20 mg/l or 30 mg/24h), twice occurring out of 3 consecutive samples over the last 5 years. - Normal UAE in the absence of conversion enzyme inhibitor or angiotensin II antagonist receptors - creatinine strictly less than 150M.2 - Case subjects (with diabetic nephropathy): - subjects with diabetic glomerulopathy confirmed by renal biopsy, even with absence of retinopathy - or subjects with the following characteristics: - diabetic retinopathy regardless of stage. - known type 2 diabetes for more than 5 years - abnormal urinary albumin excretion (UAE)(defined as urinary albumin concentration higher or equal to 20 mg/l or 30 mg/24h), twice occurring out of 3 consecutive samples over the last 5 years - with or without change to renal function (defined by creatinine higher than 150 µmol/l, or need for extra-renal purification or renal transplantation). - absence of kidney disease other than diabetic nephropathy 3 - known type 2 diabetes for at least 5 years (recent diabetes) regardless of urinary albumin excretion or creatinine |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Pathology | E11 - Type 2 diabetes mellitus |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 12/2001 |
| Date of last collection (YYYY or MM/YYYY) | 02/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | - 1100 cas/cases- 660 témoins/controls |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Renal function and glycaemic control |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA Others |
| Details of biobank content | Biobank hosted by CIC0802 (CHU de Poitiers) Serum, Plasma, urine, buffy coat, DNA |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Observation file, completed by the investigating physician, sent with consent and biological samples by express post. |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Send request to the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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