Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications
ISIS-DIAB
1 other identifier
observational
20,000
1 country
1
Brief Summary
The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives :
- Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration);
- Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes);
- Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents;
- Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 28, 2016
June 1, 2016
13.1 years
August 6, 2014
June 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genetic and environmental risk factors of T1D predisposition
10 years
Secondary Outcomes (4)
Genetic and environmental risk factors of T1D complications
10 years
Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis
5 years
Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years
4 years
Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents
5 years
Study Arms (2)
Isis-Diab patients
French T1D patients with genetic data (GWAS), and environmental data (questionnaire and environmental databases), clinical data
Isis-Diab controls
French control population with genetic data (GWAS) and environmental data (questionnaire and environmental databases
Interventions
Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data
Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotype)
Collect of clinical data on the disease and its evolution every 6 months after enrollment
Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data
Eligibility Criteria
Patients: T1D patients are enrolled into the Isis-Diab cohort, continuously, from 110 clinical diabetes centers distributed over the whole France territory. Inclusion in the cohort occurs most often soon after the initial diagnosis of T1D. This diagnosis is made according to classical criteria of autoimmune T1D. Controls: we will recruit age-matched controls among friend patients' families and among cases admitted in the participating centers for benign transient intercurrent events.
You may qualify if:
- Insulin-dependent diabetes
- European or North African geographical origin (defined by the birthplaces of the 4 grandparents), for the purpose of genetic homogeneity of the cohort
- Informed consent dated and voluntarily signed (patient and/or parents)
You may not qualify if:
- Non-insulin dependent diabetes
- MODY
- Severe psychological problems, co-morbidities that could possibly invalidate informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inserm U986
Le Kremlin-Bicêtre, 94276, France
Related Publications (1)
Balazard F, Le Fur S, Valtat S, Valleron AJ, Bougneres P; Isis-Diab collaborative group; Thevenieau D, Chatel CF, Desailloud R, Bony-Trifunovic H, Ducluzeau PH, Coutant R, Caudrelier S, Pambou A, Dubosclard E, Joubert F, Jan P, Marcoux E, Bertrand AM, Mignot B, Penformis A, Stuckens C, Piquemal R, Barat P, Rigalleau V, Stheneur C, Fournier S, Kerlan V, Metz C, Fargeot-Espaliat A, Reznic Y, Olivier F, Gueorguieva I, Monier A, Radet C, Gajdos V, Terral D, Vervel C, Bendifallah D, Signor CB, Dervaux D, Benmahammed A, Loeuille GA, Popelard F, Guillou A, Benhamou PY, Khoury J, Brossier JP, Bassil J, Clavel S, Le Luyer B, Bougneres P, Labay F, Guemas I, Weill J, Cappoen JP, Nadalon S, Lienhardt-Roussie A, Paoli A, Kerouedan C, Yollin E, Nicolino M, Simonin G, Cohen J, Atlan C, Tamboura A, Dubourg H, Pignol ML, Talon P, Jellimann S, Chaillous L, Baron S, Bortoluzzi MN, Baechler E, Salet R, Zelinsky-Gurung A, Dallavale F, Larger E, Laloi-Michelin M, Gautier JF, Guerin B, Oilleau L, Pantalone L, Lukas C, Guilhem I, De Kerdanet M, Wielickzo MC, Priou-Guesdon M, Richard O, Kurtz F, Laisney N, Ancelle D, Parlier G, Boniface C, Bockel DP, Dufillot D, Razafimahefa B, Gourdy P, Lecomte P, Pepin-Donat M, Combes-Moukhovsky ME, Zymmermann B, Raoulx M, Dumont AG. Association of environmental markers with childhood type 1 diabetes mellitus revealed by a long questionnaire on early life exposures and lifestyle in a case-control study. BMC Public Health. 2016 Sep 29;16(1):1021. doi: 10.1186/s12889-016-3690-9.
PMID: 27682602DERIVED
Biospecimen
whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre BOUGNERES, MD-PhD
Inserm U986/ Pediatric endocrinology department of the Bicêtre hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 8, 2014
Study Start
November 1, 2004
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
June 28, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share