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ClinicalIndex Comparison Record
N/ACompleted· 207 enrolled
Drug / intervention
Genetic susceptibility determination +3 moregenetic
Likely dose
Not stated in record
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NCT02575001N/ACompleted
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The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes

University of Ljubljana, Faculty of Medicine·observational·Posted Oct 14, 2015·Updated Feb 11, 2020

In Brief

An observational study evaluating Psychological background determinations, Genetic susceptibility determination, and 2 other interventions for Type 1 Diabetes and Stress. Completed, enrolled 207 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Stress
CountriesSlovenia
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 14, 2015
Enrollment StartJul 1, 2015
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.7 years ago

Interventions

Psychological background determinationsbehavioral

For the psychological background determinations a structured interview and questionnaires will be administered: 1. Child Attachment Interview (CAI) 2. General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy 3. "Parenting Stress Index" with the "19-item Life Stress Scale" (PSI) 4. Achenbach System of Empirically Based Assessment (CBCL, YSR) 5. Holmes and Rahe "Social readjustment rating scale" 6. Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P) 7. Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)

Genetic susceptibility determinationgenetic

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 testprocedure

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

Saliva cortisol measurementprocedure

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