The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT02575001 |
Recruitment Status :
Completed
First Posted : October 14, 2015
Last Update Posted : February 11, 2020
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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 |
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 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 |

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:
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:
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 |
- 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
- 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

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Ages Eligible for Study: | 8 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575001
Slovenia | |
University of Ljubljana, Faculty of Medicine | |
Ljubljana, Slovenia, 1000 |
Principal Investigator: | Tadej Battelino, MD, PhD | University of Ljubljana, Faculty of Medicine |
Responsible Party: | University of Ljubljana, Faculty of Medicine |
ClinicalTrials.gov Identifier: | NCT02575001 |
Other Study ID Numbers: |
Attachment2015 |
First Posted: | October 14, 2015 Key Record Dates |
Last Update Posted: | February 11, 2020 |
Last Verified: | February 2020 |
Type 1 diabetes Children and adolescents Stress Genetic factors Psychological background |
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 |