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

February 9, 2020 updated by: University of Ljubljana, Faculty of Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University of Ljubljana, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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:

  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
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:

  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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana, Faculty of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

October 11, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 9, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Attachment2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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