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

NCT02575001 | Completed

• 1 other identifier: Attachment2015
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Significant differences in psychological scores between groups

  1 week

Study Arms (2)

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; Genetic: Genetic susceptibility determination; Procedure: Cortisol release test; Procedure: Saliva cortisol measurement

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; Genetic: Genetic susceptibility determination; Procedure: Saliva cortisol measurement

Interventions

Psychological background determinations BEHAVIORAL

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)

Healthy control; Type 1 diabetes

Genetic susceptibility determination GENETIC

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.

Healthy control; Type 1 diabetes

Cortisol release test PROCEDURE

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

Type 1 diabetes

Saliva cortisol measurement PROCEDURE

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; Type 1 diabetes

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Ljubljana, Faculty of Medicine: lead

Study Sites (1)

University of Ljubljana, Faculty of Medicine

Ljubljana, 1000, Slovenia

Location

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Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tadej Battelino, MD, PhD

  University of Ljubljana, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: October 14, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

SL (1)