Clinical trial NCT02575001: The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
Official title: The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Stress
Keywords: Type 1 diabetes
Children and adolescents
Stress
Genetic factors
Psychological background
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 207
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of 8 to 15 years of age with type 1 diabetes with their parents; Healthy primary school pupils of 8 to 15 years of age with their parents

Brief summary: The aims of this study are two fold: To show whether there is an increased environmental or genetic susceptibility to stress in patients with T1D and whether it influences diabetes management. And to develop a strategy for the assessment and treatment of patients with T1D and an increased risk for development of psychopathology under stress.

Detailed description: Lately, a marked increase in the incidence and earlier age of onset of type 1 diabetes (T1D) has been noted. These observations could also be connected to an increased prevalence of stressful experiences and a lowered stress tolerance in some children.

The way a person responds to stress is determined by the interplay of genetic and environmental factors. Environmental experiences at specific times of development have been shown to shape individual's hypothalamic-pituitary-adrenal axis (HPA axis) stress response. It is known, that early development of central nervous system is critically dependent on child's interaction with the environment (experience dependent maturation), especially to the attachment to caregivers (most often the mother). Appropriate caregiving is connected to lower basal cortisol levels in children and a more stable HPA axis response after the exposure to stress. Any circumstances that disturbed the formation of the attachment to the primary caregiver (e.g. complications at delivery, psychosocial stressors affecting the mother or mother's postpartum depression) resulted in higher HPA axis responsiveness to stress in the affected children.

Changes in individual genes have also been shown to influence a person's susceptibility to stress and risk for the development of stress-induced psychopathology.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry
* Diagnosed with Type 1 DM prior to signature of Patient Informed Consent (PIC) (for the T1D group).
* Age between 8-15 years old (inclusive) at signature of PIC
* Treated by the investigator's centre prior signature of PIC (For the T1D group).
* Willing to undergo all study procedures

Exclusion Criteria:

* Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease)
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability).

Primary outcomes:
measure: Significant between group differences in metabolic control
timeFrame: 1 month
Secondary outcomes:
measure: Significant differences in psychological scores between groups
timeFrame: 1 week
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University of Ljubljana, Faculty of Medicine
Study officials:
affiliation: University of Ljubljana, Faculty of Medicine
name: Tadej Battelino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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