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

University of Ljubljana, Faculty of Medicine

Status: Completed

Conditions: Type 1 Diabetes; Stress

Treatments: Procedure: Cortisol release test; Behavioral: Psychological background determinations; Genetic: Genetic susceptibility determination; Procedure: Saliva cortisol measurement

Study type: Observational

Funder types: Other

Identifiers

NCT02575001

Attachment2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

207 participants in 2 patient groups

Type 1 diabetes

Description:

Children with Type 1 diabetes, age from 8 to 15 years. The following interventions/exposures will be administered: Behavioral: Psychological background determinations, Genetic: Genetic susceptibility determination, Procedure/Surgery: Cortisol release test, Procedure/Surgery: Saliva cortisol measurement.

Treatment:

Procedure: Cortisol release test

Genetic: Genetic susceptibility determination

Procedure: Saliva cortisol measurement

Behavioral: Psychological background determinations

Healthy control

Description:

Healthy primary school pupils, age from 8 to 15 years. The following interventions/exposures will be administered: Behavioral: Psychological background determinations, Genetic: Genetic susceptibility determination, Procedure/Surgery: Saliva cortisol measurement.

Treatment:

Genetic: Genetic susceptibility determination

Procedure: Saliva cortisol measurement

Behavioral: Psychological background determinations