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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575001
• Other study ID #: Attachment2015
• Status: Completed
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Stress
• Type 1 Diabetes

Intervention

Behavioral:
• Psychological background determinations
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:
• 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
• 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

Locations

Country	Name	City	State
Slovenia	University of Ljubljana, Faculty of Medicine	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant between group differences in metabolic control	Association between psychological scores, stress reactivity, genetic factors and metabolic control in patients with type 1 diabetes	1 month
Secondary	Significant differences in psychological scores between groups	Significant differences in psychological scores between the patients with type 1 diabetes and the control group	1 week