NCT02575001

The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 207 (actual)
• Sponsor: University of Ljubljana, Faculty of Medicine · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 1 Diabetes
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Psychological background determinations	For the psychological background determinations a structured interview and questionnaires will be administered: 1. Child Attachment Interview (CAI) 2. General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy 3. "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI) 4. Achenbach System of Empirically Based Assessment (CBCL, YSR) 5. Holmes and Rahe "Social readjustment rating scale" 6. Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P) 7. Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)
GENETIC	Genetic susceptibility determination	DNA will be isolated from the patients' blood samples and form the control subjects buccal swabs. The genes with expected influence to stress reactivity and mental disorders will be tested.
PROCEDURE	Cortisol release test	Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity
PROCEDURE	Saliva cortisol measurement	Saliva cortisol measurement - will be used with the patients before and after the Synacthen test and with the Hashimoto thyroiditis and the healthy control group before and after the Child Attachment Interview

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-10-14
• Last updated: 2020-02-11

Locations

1 site across 1 country: Slovenia