NCT06317454

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

March 12, 2024

Last Update Submit

March 12, 2024

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetesMetabolic control

Outcome Measures

Primary Outcomes (2)

  • Identification of environmental factors affecting T1DM metabolic control

    Through study completion, an average of 18 months

  • 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

Study Arms (2)

Subjects with T1DM

Diagnostic Test: Blood and saliva analysis

Control subjects

Diagnostic Test: Blood and saliva analysis

Interventions

Blood and saliva analysisDIAGNOSTIC_TEST

Phenotyping and genotyping characterization using blood and saliva

Control subjectsSubjects with T1DM

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients between 6 and 21 years with or without type 1 diabetes

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Antonietta Robino

CONTACT

+39.040.785.470antonietta.robino@burlo.trieste.it

Gianluca Tornese, MD Phd

CONTACT

+39.040.785.470gianluca.tornese@burlo.trieste.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

November 11, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

IT(1)