Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus
NCT ID: NCT06317454
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2021-11-11
2024-12-31
Brief Summary
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While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.
This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Subjects with T1DM
Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva
Control subjects
Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva
Interventions
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Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva
Eligibility Criteria
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Inclusion Criteria
* age between 6 and 21 years;
* patients suffering from type 1 diabetes
Controls:
* age between 6 and 21 years;
* patients for whom a venous sampling is planned
Exclusion Criteria
* patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
* patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...)
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
Controls:
* subjects with type 1 and 2 diabetes
* obese subjects and those with a family history of diabetes and obesity or other metabolic disorders
* subjects with HbA1c \>6%
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
6 Years
21 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Locations
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Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GR-2019-12369573
Identifier Type: -
Identifier Source: org_study_id
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