Diabetes MellitusISIS-VIRUSNCT02425410
Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset
An observational study of Diabetes Mellitus and Insulin-Dependent, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- Collect of data on viral environment of T1D patients and Collect of blood samples for DNA extraction and genetic characterization (GWAS)
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of the Isis-Diab cohort, i.e. T1D patients aged more than 6 months, already sampled for genetic analysis.
Who may be able to join
- Type 1 diabetic patients included in the Isis-Diab cohort
- Patients with available genetic data (GWAS)
Who cannot join
- Patient refusal (or parents) to participate in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Inserm U986
Le Kremlin-Bicêtre, 94276
Sophie Le Fur, PhD, + 33 1 49 59 53 43, sophie.le-fur@inserm.fr
Laurence Lecomte, PhD, +33 1 71 19 64 94, laurence.lecomte@nck.aphp.fr
About this study
The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators could attempt to identify gene-virus interactions determining the age of T1D onset.
Read the detailed description
The "hygiene hypothesis", which has been proposed to explain the observed increase of the incidence of T1D, relies on experimental evidence acquired in mouse models. However, epidemiological data are still lacking to validate this hypothesis in man. This is critical, because -in opposition with the hygiene hypothesis- there are many reasons to believe that, at contrary, certain virus can trigger the disease.
Genetic predisposition to a severe infection form (particularly primary infection) was demonstrated for several infectious diseases (Casanova JL, Science 317:617-619, 2007; Casanova JL, EMBO J 26:915-922, 2007). It usually corresponds to deficiencies in genes involved in the host's immune response, the transmission of which being Mendelian. Genetic factors affect the ability of enteroviruses and other viruses to damage beta cells and to induce diabetes. Recently, Nejentsev et al have demonstrated a link between enteroviruses and diabetes genes: they have indeed identified 4 rare IFIH1 polymorphisms that reduce the T1D risk. However, this gene encodes an enzyme recognizing the DNA enterovirus, causing immunity activation; mutations inhibit gene activation. Except one study on HIV-1, there is to our knowledge no genome wide association studies (GWAS) in humans on the role of host's genetic polymorphisms in the risk of infection, clinical expression, duration of viral shedding, or response to therapy or to anti-viral vaccines.
We relied on our cohort of T1D children (Isis-Diab) to investigate the possible relation between viral exposures, genetic polymorphisms, and subsequent T1D.
The search for viral factors responsible for the increased T1D prevalence in youth children is difficult to implement. The absence or scarcity of infections is difficult to assess robustly at the individual level. The analysis of digestive, ENT or blood samples in the search for viruses themselves can only be done at T1D diagnosis and is therefore unlikely to be positive several years after the causal infection. It is not possible to reconstitute retrospectively viral events, which an individual has been exposed between birth and date of diabetes diagnosis. That is why our project proposes to use a proxy of viral infections crossed by a child, quantifying viral exposures to which he was submitted before the T1D diagnosis. We focused on early childhood's viral infections that may interfere with early forms of T1D. We combine 2 data sources:
- The geolocation of the child's address will locate places where he lives. Spatio-temporal data from Sentinel Network, collected since 1984, will provide access on the following viral exposures: seasonal influenza, viral diarrhea (mostly enteroviral), mumps, measles, chickenpox. If the defect of our approach is that it does not see real viral infections experienced by children, but only the level of exposure to which they were exposed according to their address, the advantage is an objective spatio-temporal description of virus epidemics around children, making it more or less likely infection of these. Only France has such Sentinel data.
- Vaccination (including MMR) and information on infectious past of children will be collected from data recorded in his book health. We will focus on the mother's pregnancy and the child between birth and 2 years of age.
Environmental data from these 2 sources will be crossed with already available genetic data from GWAS to identify gene-virus associations potentially determining age of T1D onset. This "high dimensionality" analysis will be addressed with "machine learning" programs.
If avoidable risks are identified, it would be possible to think to design clinical trials for prevention of the identified forms of T1D.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- Collect of data on viral environment of T1D patients, Collect of blood samples for DNA extraction and genetic characterization (GWAS)
- Keywords
- Diabetes Mellitus, Insulin-Dependent, Virus Diseases, Questionnaires, Risk assessment, Genome-Wide Association Study
- Medical subject headings
- Diabetes Mellitus, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect of data on viral environment of T1D patientsOther
Questionnaires on viral events 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)Genetic
Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotypage)
| Study group | Role | What they receive |
|---|---|---|
| Isis-Virus | T1D patients of the Isis-Diab cohort with genetic data (GWAS) and specific environmental data on viral events during childhood Receives: Other: Collect of data on viral environment of T1D patients; Genetic: Collect of blood samples for DNA extraction and genetic characterization (GWAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of viral events before T1D diagnosis
Measured: From birth to 2 years
Delay between viral events and T1D diagnosis
Measured: From birth to 2 years
Secondary outcomes (1)
Age at T1D diagnosis as a quantitative trait
Measured: From birth to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMar 2010
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de Génotypage, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Alain-Jacques Valleron, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FrancePierre Bougnères, MD, PhD, Study director, Inserm U986 / Pediatric endocrinology department of the Bicêtre Hospital (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425410
- Sponsor's protocol ID
- AOM 10061
- Acronym
- ISIS-VIRUS
- Status last verified
- Jun 2016
- First submitted
- 7 Aug 2014
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset
- ClinicalTrials.gov ID
- NCT02425410
- Acronym / sponsor ID
- ISIS-VIRUS / AOM 10061
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- Diabetes Mellitus, Insulin-Dependent, Virus Diseases, Questionnaires, Risk assessment, Genome-Wide Association Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de Génotypage, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators could attempt to identify gene-virus interactions determining the age of T1D onset.
Detailed description
The "hygiene hypothesis", which has been proposed to explain the observed increase of the incidence of T1D, relies on experimental evidence acquired in mouse models. However, epidemiological data are still lacking to validate this hypothesis in man. This is critical, because -in opposition with the hygiene hypothesis- there are many reasons to believe that, at contrary, certain virus can trigger the disease.
Genetic predisposition to a severe infection form (particularly primary infection) was demonstrated for several infectious diseases (Casanova JL, Science 317:617-619, 2007; Casanova JL, EMBO J 26:915-922, 2007). It usually corresponds to deficiencies in genes involved in the host's immune response, the transmission of which being Mendelian. Genetic factors affect the ability of enteroviruses and other viruses to damage beta cells and to induce diabetes. Recently, Nejentsev et al have demonstrated a link between enteroviruses and diabetes genes: they have indeed identified 4 rare IFIH1 polymorphisms that reduce the T1D risk. However, this gene encodes an enzyme recognizing the DNA enterovirus, causing immunity activation; mutations inhibit gene activation. Except one study on HIV-1, there is to our knowledge no genome wide association studies (GWAS) in humans on the role of host's genetic polymorphisms in the risk of infection, clinical expression, duration of viral shedding, or response to therapy or to anti-viral vaccines.
We relied on our cohort of T1D children (Isis-Diab) to investigate the possible relation between viral exposures, genetic polymorphisms, and subsequent T1D.
The search for viral factors responsible for the increased T1D prevalence in youth children is difficult to implement. The absence or scarcity of infections is difficult to assess robustly at the individual level. The analysis of digestive, ENT or blood samples in the search for viruses themselves can only be done at T1D diagnosis and is therefore unlikely to be positive several years after the causal infection. It is not possible to reconstitute retrospectively viral events, which an individual has been exposed between birth and date of diabetes diagnosis. That is why our project proposes to use a proxy of viral infections crossed by a child, quantifying viral exposures to which he was submitted before the T1D diagnosis. We focused on early childhood's viral infections that may interfere with early forms of T1D. We combine 2 data sources:
- The geolocation of the child's address will locate places where he lives. Spatio-temporal data from Sentinel Network, collected since 1984, will provide access on the following viral exposures: seasonal influenza, viral diarrhea (mostly enteroviral), mumps, measles, chickenpox. If the defect of our approach is that it does not see real viral infections experienced by children, but only the level of exposure to which they were exposed according to their address, the advantage is an objective spatio-temporal description of virus epidemics around children, making it more or less likely infection of these. Only France has such Sentinel data.
- Vaccination (including MMR) and information on infectious past of children will be collected from data recorded in his book health. We will focus on the mother's pregnancy and the child between birth and 2 years of age.
Environmental data from these 2 sources will be crossed with already available genetic data from GWAS to identify gene-virus associations potentially determining age of T1D onset. This "high dimensionality" analysis will be addressed with "machine learning" programs.
If avoidable risks are identified, it would be possible to think to design clinical trials for prevention of the identified forms of T1D.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isis-Virus | – | Other: Collect of data on viral environment of T1D patients, Genetic: Collect of blood samples for DNA extraction and genetic characterization (GWAS)T1D patients of the Isis-Diab cohort with genetic data (GWAS) and specific environmental data on viral events during childhood |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of the Isis-Diab cohort, i.e. T1D patients aged more than 6 months, already sampled for genetic analysis.
Key inclusion criteria (2 listed)
- Type 1 diabetic patients included in the Isis-Diab cohort
- Patients with available genetic data (GWAS)
Key exclusion criteria (1 listed)
- Patient refusal (or parents) to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect of data on viral environment of T1D patientsQuestionnaires on viral events during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data | Other | Isis-Virus |
| Collect of blood samples for DNA extraction and genetic characterization (GWAS)Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotypage) | Genetic | Isis-Virus |
Primary outcome
Occurrence of viral events before T1D diagnosis
Time frame: From birth to 2 years
Delay between viral events and T1D diagnosis
Time frame: From birth to 2 years
1 secondary outcome
Age at T1D diagnosis as a quantitative trait
Time frame: From birth to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- public web-site of the Isis-Diab cohortLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain-Jacques Valleron, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Pierre Bougnères, MD, PhD study director
Inserm U986 / Pediatric endocrinology department of the Bicêtre Hospital (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Insulin-Dependent, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Le Fur, PhD (+33 1 49 59 53 43, sophie.le-fur@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of viral events before T1D diagnosis (time frame: From birth to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.