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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02575001 |
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Date of registration:
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23/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
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Scientific title:
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The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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207 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02575001 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Tadej Battelino, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ljubljana, Faculty of Medicine |
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Key inclusion & exclusion criteria
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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).
Age minimum:
8 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stress
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Type 1 Diabetes
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Intervention(s)
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Procedure: Saliva cortisol measurement
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Procedure: Cortisol release test
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Behavioral: Psychological background determinations
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Genetic: Genetic susceptibility determination
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Primary Outcome(s)
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Significant between group differences in metabolic control
[Time Frame: 1 month]
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Secondary Outcome(s)
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Significant differences in psychological scores between groups
[Time Frame: 1 week]
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Secondary ID(s)
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Attachment2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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