ITMO public health
Last update : 01/22/2019 | Version : 4 | ID : 4071
| General | |
| Identification | |
| Detailed name | Genetic Polymorphism in Subjects with Type 2 Diabetes and Longitudinal Analysis of Renal Function: “SURDIAGENE” Study (SUivi Rénal , DIAbète de type 2 et GENEtique) |
| Sign or acronym | SURDIAGENE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP : N°03.10.19 du 24/11/2003 ; DGS 2003/0530 du 15/12/2003 ; CNIL : en attente |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Urology, andrology and nephrology |
| Health determinants |
Genetic Medicine Nutrition |
| Keywords | Health episodes, renal function, cardiovascular, death, population, health system |
| Scientific investigator(s) (Contact) | |
| Name of the director | Hadjadj |
| Surname | Samy |
| Address | Centre d'investigation Clinique - Inserm 1402 ; 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 | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | PHRC régional 2000 / PHRC interrégional 2004 / association GEMMS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de Poitiers |
| Organisation status |
Public |
| Additional contact | |
| Name of the contact | GROSDENIER |
| Surname | Michele |
| Address |
Centre d eRessources Biologiaues 5 cour Est Jean Bernard ; BP 577 ; 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) |
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: 01/01/2009 Number of required subjects: [1,000-5,000] Details regarding this number: Initial calculation based on data from genotype frequency less relevant in 2009 compared to 2002 (date of conception). |
| Database objective | |
| Main objective | MAIN: to investigate the genetic determinants associated with changes in renal function (changes in creatinine clearance) SECONDARY: 1. - to investigate the genetic determinants associated with changes in urinary albumin excretion 2 - to investigate the genetic determinants associated with other degenerative complications of diabetes (retinopathy, cardiovascular events) |
| Inclusion criteria | B1. Type 2 diabetes (T2D): Subjects from the SURDIAGENE study with T2D. The distinction between type 1 (TD1) and type 2 (T2D) diabetes is sometimes difficult. We define criteria for T2D diagnosis as: - age at diagnosis is 35 years old or over - apparent insulin-dependence after more than 2 years following diabetes diagnosis - absence of secondary diabetes - absence of ketonuria at diagnosis B2: Longitudinal follow-up: Subjects in the SURDIAGENE study with T2D who are being monitored for diabetes for at least one year, which includes a collection of clinical (blood pressure, weight) and biological data (glycated haemoglobin, serum creatinine, urinary albumin excretion) to analyse the progression of renal disease and other degenerative (retinal and cardiovascular) complications B3. Exclusion criteria is defined as: Subjects who are not permitted to participate in the SURDIAGENE study are subjects who a) fulfil medical criteria for exclusion - do not have diabetes or have T1D or secondary diabetes - are presenting renal disease caused by non-diabetic renal insufficiency (arterial hypertension is not considered as part of the exclusion criteria, except if hypertensive nephropathy precedes discovery of diabetes). - proteinuria at time of diabetes diagnosis - non-diabetic glomerular nephropathy confirmed by renal biopsy - pure vascular nephropathy - confirmed glomerular haematuria or malformed uropathy - chronic interstitial nephritis with history of pyelonephritis or persistent urinary tract infections - follow-up is less than 1 year b) fulfilling legal exclusion criteria (amended law dated 20th December 1988) - minors - adults protected by law - deprived of liberty - brain-dead - who have not given their written participation consent - women who are pregnant, parturient or breastfeeding - not affiliated to social security |
| Population type | |
| Age |
Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Pathology | E11 - Type 2 diabetes mellitus |
| Gender |
Male Woman |
| Geography area |
Local |
| Detail of the geography area | Poitiers (Vienne) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 12/2003 |
| Date of last collection (YYYY or MM/YYYY) | 2020 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1200 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Renal function and glycaemic control: Renal function is based on a measurement of plasma creatinine and estimated glomerular filtration rate (GFR estimated by MDRD and CKD-EPI equations). Diabetic renal insufficiency (initial and during follow-up) is equally characterised by urinary albumin excretion and urinary albumin/urinary creatinine ratio. The level of renal impairment as well as GFR can be established as such. Glycaemic control rate is calculated by measuring glycated haemoglobin (HbA1c). |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA Others |
| Details of biobank content | Other: urine, buffy coat |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview: input from a paper questionnaire (manual input) with double entry Clinical examinations: handwritten (manual input) with double data entry Biological analysis: direct input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDC |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=SURDIAGENE |
| Description | List of publications in Pubmed |
| Link to the document | Surdiagene.pdf |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Send request to 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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