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Completed

NCT Number: NCT02575001

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

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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ljubljana, Faculty of Medicine

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psychological background determinations

Behavioral

For the psychological background determinations a structured interview and questionnaires will be administered:

  • Child Attachment Interview (CAI)
  • General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy
  • "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI)
  • Achenbach System of Empirically Based Assessment (CBCL, YSR)
  • Holmes and Rahe "Social readjustment rating scale"
  • Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P)
  • Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)

Genetic susceptibility determination

Genetic

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.

Cortisol release test

Procedure

Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity

Saliva cortisol measurement

Procedure

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

Primary outcomes

  1. Significant between group differences in metabolic control

    Time frame: 1 month

    Association between psychological scores, stress reactivity, genetic factors and metabolic control in patients with type 1 diabetes

Secondary outcomes

  1. Significant differences in psychological scores between groups

    Time frame: 1 week

    Significant differences in psychological scores between the patients with type 1 diabetes and the control group

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2015
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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