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Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus

Genetic and Environmental Determinants of Metabolic Control in Children and Young Adults With Type 1 Diabetes Mellitus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06317454
Enrollment
800
Registered
2024-03-19
Start date
2021-11-11
Completion date
2024-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes, Metabolic control

Brief summary

A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic. 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

Interventions

DIAGNOSTIC_TESTBlood and saliva analysis

Phenotyping and genotyping characterization using blood and saliva

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

Cases: * 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

Cases: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of environmental factors affecting T1DM metabolic controlThrough study completion, an average of 18 months
Identification of genetic factors affecting T1DM metabolic controlThrough study completion, an average of 18 monthsIdentify genetic factors responsible of differences in T1DM metabolic control and thus uncover genes of potential biological therapeutic importance

Countries

Italy

Contacts

Primary ContactAntonietta Robino
antonietta.robino@burlo.trieste.it+39.040.785.470
Backup ContactGianluca Tornese, MD Phd
gianluca.tornese@burlo.trieste.it+39.040.785.470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026