Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus

March 12, 2024 updated by: IRCCS Burlo Garofolo

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control subjects
Diagnostic test: Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva
Subjects with T1DM
Diagnostic test: Blood and saliva analysis
Phenotyping and genotyping characterization using blood and saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of environmental factors affecting T1DM metabolic control
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months
Identification of genetic factors affecting T1DM metabolic control
Time Frame: 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
Through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Burlo Garofolo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2019-12369573

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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