Understanding factors affecting metabolic control in children with type 1 diabetes
Genetic and Environmental Determinants of Metabolic Control in Children and Young Adults With Type 1 Diabetes Mellitus
This study is trying to find out how genetics and environment affect blood sugar control in children and young adults with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT06317454 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the genetic and environmental factors that influence metabolic control in children and young adults with type 1 diabetes mellitus (T1DM). By creating a comprehensive database of genetic and phenotypic data, the study seeks to evaluate how these factors may predict glycemic control trajectories. Participants will undergo blood and saliva analysis to gather necessary data. The findings could enhance understanding of metabolic control in T1DM and inform future management strategies.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 6 to 21 years diagnosed with type 1 diabetes mellitus.
Not a fit: Patients with other types of diabetes or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing type 1 diabetes in children, potentially reducing long-term complications.
How similar studies have performed: While there has been significant research on the genetic factors of T1DM onset, studies specifically addressing genetic influences on metabolic control are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Antonietta Robino
- Email: antonietta.robino@burlo.trieste.it
- Phone: +39.040.785.470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.