To characterize the interaction between the genetic background, the microbiome, and the immune responses in patients with diabetes type 1, both cross-sectional and over time, and to identify the disturbances in this interaction.
ID
Source
Brief title
Condition
- Other condition
- Immunodeficiency syndromes
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Health condition
autoimmuunziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Metadata: Lifestyle questionnaires
DNA: Gene polymorphisms at DNA level
Microbiome: Presence of groups of bacteria
Phenotype: Specific populations of cells
Functional data: Cytokine production
Secondary outcome
nvt
Background summary
Rationale: The response of the host to exogenous (e.g. infectious) or
endogenous (e.g. metabolic) stressors depends on the genetic make-up of the
host on the one hand, and environmental factors on the other hand. One of the
most important environmental components that influences human physiological
responses is the colonizing microbial flora. In a healthy human body, more
microbial cells are present on the skin and mucosae (e.g. oral, gut, vagina)
than normal human cells. Due to the important effects of the colonizing
microflora for multiple biological processes (e.g. host defense, digestion,
etc), a finely tuned balance between the microorganisms that form the
microbiome and the host is very important for the maintenance of health. This
balance might be disturbed in people suffering from chronic inflammatory
diseases, infections or metabolic diseases.
It has been recently hypothesized that these two factors, genetic and
environmental (in this case the microbiome), strongly influence each other and
the immune system of the host. Furthermore, it has been demonstrated that
microbiome composition can change over time and seasonal changes have been
reported. In this respect, the interaction between the genome, the microbiome
and the immune response becomes crucial for the health status of an individual
and for the development of disease. Therefore, a comprehensive analysis of the
genome-microbiome-host defense interaction is currently performed in 500
healthy individuals (500FG project, 2012-550, NL42561.091.12). However, it is
not known how this interaction is affected in patients with infections or
inflammatory diseases.
Study objective
To characterize the interaction between the genetic background, the microbiome,
and the immune responses in patients with diabetes type 1, both cross-sectional
and over time, and to identify the disturbances in this interaction.
Study design
The explorative study will be performed in the RadboudUMC The duration of the
study is 3 years. This explorative study starts with recruiting patients at the
RadboudUMC.
Study burden and risks
Burden:
- For patients: collection of venous blood, if possible during regular blood
sampling. This comprises a maximum of 1 PaxGene tube a 8 mL, and 6 EDTA tubes à
10 ml and 1 serum tube à 5 ml.
Risks:
- No risks other than local hematoma are related to venous puncture.
Benefit:
There will be no benefits for the subjects enrolled in this study.
Geert Grooteplein zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
age > 18 years
diagnosis type 1 diabetes based on clinical criteria with or without anti-GAD positivity
Exclusion criteria
Pregnancy or breastfeeding during inclusion period
Age<18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54214.091.15 |