Determinants of Glycaemic Control in Children With Type 1 Diabetes

March 15, 2024 updated by: IRCCS Burlo Garofolo

Exploring Genetic, Epigenetic and Environmental Determinants of Glycaemic Control in Children and Young Individuals With Type 1 Diabetes

Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.

While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.

However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic 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 Locations

  • Italy
      • Trieste, Italy, 34137
        • Recruiting
        • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
        • Contact:

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

T1D subjects (children and young adults) attending to several Diabetes Units of Italian and European institutions

Description

Inclusion Criteria:

  • Type 1 diabetes subjects
  • Age from 6 to 20 years old
  • At least 5 years of duration of disease

Exclusion Criteria:

  • Type 1 diabetes subjects incapable of giving valid informed consent or whose parents are incapable of giving valid informed consent.
  • Type 1 diabetes subjects for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
  • Subjects with other types of diabetes (i.e. type 2, monogenic diabetes, cystic fibrosis related diabetes)

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
Patients with T1D and optimal glycaemic control
Optimal glycaemic control will be defined as HbA1c values <7%
Other: Determinants of T1D glycaemic control
DNA genotyping, microbiome, DNA methylation and microRNAs analysis
Patients with T1D and poor glycaemic control
Poor glycemic control will be defined as HbA1c value ≥7%
Other: Determinants of T1D glycaemic control
DNA genotyping, microbiome, DNA methylation and microRNAs analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of genes involved in T1D glycaemic control
Time Frame: Through study completion, an average of 18 months
DNA will be isolated from saliva by Genefix Saliva DNA/RNA collection kit (Isohelix, UK) and whole genome genotyping will be performed using Illumina chip arrays (CA, USA).
Through study completion, an average of 18 months
Identification of DNA methylation patterns involved in T1D glycaemic control
Time Frame: Through study completion, an average of 18 months
Peripheral blood will be collected from each participant into EDTA-containing tubes and Genome-wide DNA methylation will be performed using the Illumina Infinium Human Methylation EPIC BeadChip array
Through study completion, an average of 18 months
Identification of microRNAs involved in T1D glycaemic control
Time Frame: Through study completion, an average of 18 months
Peripheral blood will be collected from each participant into Ethylenediaminetetraacetic acid (EDTA)-containing tubes for microRNAs sequencing. Illumina TruSeq Small RNA Sample Preparation kit will be used for library preparation, and sequencing will be conducted by Illumina platform (CA, USA).
Through study completion, an average of 18 months
Identification of oral microbiome characteristics associated to T1D glycaemic control
Time Frame: Through study completion, an average of 18 months
Bacterial DNA will be extracted from saliva and a 500 base pair region of the V1-V3 portion of the 16S ribosomal RNA gene as well as the 200 base pair region of the V3 portion will be amplified. The V3 amplicon will be used for template preparation and will be sequenced using the Ion PGM Hi-Q View sequencing kit (Life Technologies, New York, NY, USA) with the IonPGM™System technology
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)

May 29, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 06/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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