Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317454
• Other study ID #: GR-2019-12369573
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: IRCCS Burlo Garofolo
• Contact: Antonietta Robino
• Phone: +39.040.785.470
• Email: antonietta.robino[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Diagnostic Test:
• Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of environmental factors affecting T1DM metabolic control		Through study completion, an average of 18 months
Primary	Identification of genetic factors affecting T1DM metabolic control	Identify genetic factors responsible of differences in T1DM metabolic control and thus uncover genes of potential biological therapeutic importance	Through study completion, an average of 18 months