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

• ClinicalTrials.gov Identifier: NCT02575001
• Recruitment Status: Completed
• First Posted: October 14, 2015
• Last Update Posted: February 11, 2020
• Sponsor: University of Ljubljana, Faculty of Medicine
• Information provided by (Responsible Party): University of Ljubljana, Faculty of Medicine

Study Description

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.

Condition or disease	Intervention/treatment
Type 1 Diabetes; Stress	Behavioral: Psychological background determinations; Genetic: Genetic susceptibility determination; Procedure: Cortisol release test; Procedure: Saliva cortisol measurement

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 207 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
• Actual Study Start Date: July 2015
• Actual Primary Completion Date: December 2019
• Actual Study Completion Date: December 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Type 1 diabetes; 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.	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; 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
Healthy control; 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.	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: 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

The genes with expected influence to stress reactivity and mental disorders will be tested.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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).

Contacts and Locations

Locations

Slovenia

University of Ljubljana, Faculty of Medicine

Ljubljana, Slovenia, 1000

Sponsors and Collaborators

University of Ljubljana, Faculty of Medicine

Investigators

• Principal Investigator: Tadej Battelino, MD, PhD; University of Ljubljana, Faculty of Medicine

More Information

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• Responsible Party: University of Ljubljana, Faculty of Medicine
• ClinicalTrials.gov Identifier: NCT02575001
• Other Study ID Numbers: Attachment2015
• First Posted: October 14, 2015
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

Keywords provided by University of Ljubljana, Faculty of Medicine:

Type 1 diabetes; Children and adolescents; Stress; Genetic factors; Psychological background

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Anti-Inflammatory Agents