Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575001
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

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.

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

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
The genes with expected influence to stress reactivity and mental disorders will be tested.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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).

Information from the National Library of Medicine

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


Locations
Layout table for location information
Slovenia
University of Ljubljana, Faculty of Medicine
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Tadej Battelino, MD, PhD University of Ljubljana, Faculty of Medicine
Publications:
Target M, Fonagy P, Shmueli-Goetz Y. Attachment Representations in School-Age Children: The Development of the Child Attachment Interview (CAI). Journal of Child Psychotherapy2003;29:171-86.
Abidin RR. Parenting stress index. Professional manual. Third ed. Lutz: PAR; 1995.

Layout table for additonal information
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
Keywords provided by University of Ljubljana, Faculty of Medicine:
Type 1 diabetes
Children and adolescents
Stress
Genetic factors
Psychological background
Additional relevant MeSH terms:
Layout table for MeSH terms
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