Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Diagnostic Test: Blood and saliva analysis

• Registration Number: NCT06317454
• Lead Sponsor: IRCCS Burlo Garofolo

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control subjects	Blood and saliva analysis	-
Subjects with T1DM	Blood and saliva analysis	-

Primary Outcome Measures

Name	Time	Method
Identification of genetic factors affecting T1DM metabolic control	Through study completion, an average of 18 months	Identify genetic factors responsible of differences in T1DM metabolic control and thus uncover genes of potential biological therapeutic importance
Identification of environmental factors affecting T1DM metabolic control	Through study completion, an average of 18 months

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"; 🇮🇹 Trieste, Italy