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

NCT02575001 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 207

Last updated 2020-02-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Psychological background determinations

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

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

Sponsors & Collaborators

  • University of Ljubljana, Faculty of Medicine

    lead OTHER

Principal Investigators

  • Tadej Battelino, MD, PhD · University of Ljubljana, Faculty of Medicine

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575001 on ClinicalTrials.gov