Mechanisms of Type 1 Diabetes Endophenotypes

Recruiting

• Conditions: Type 1 Diabetes Mellitus; Genetic Predisposition to Disease
• Interventions: Genetic: Genome sequencing

• Registration Number: NCT05764850
• Lead Sponsor: Pediatric Clinical Research Platform

Brief Summary

The goal of this observational study consists of performing cluster analysis to decipher underlying disease mechanisms of type 1 diabetes in children and young adults.

To this end, we will combine clinical, laboratory, genetic, transcriptomic, and metabolomic datasets of an extensively phenotyped cohort of children and young adults with type 1 diabetes. We will also assess the risk for cardiovascular diseases in this most vulnerable diabetes cohort.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Genome sequencing	50 control patients
Case	Genome sequencing	100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort

Primary Outcome Measures

Name	Time	Method
Cluster analysis to decipher underlying mechanisms of type 1 diabetes	blood sampling and analyses	We will combine clinical, laboratory, genetic, transcriptomic, and metabolomic datasets of an extensively phenotyped cohort of type 1 diabetes patients (Children and young adults).; We will create clinical and genetic correlates with the following clinical parameters: Age at diabetes onset (years), disease duration (years), BMI (kg/m2), diabetes autoantibodies, C-peptide level (pmol/l) and decline over time, HbA1c (%), insulin dose (U/kg/d), ketoacidosis at disease onset (y/n), lipid levels (Total cholesterol, triglycerides, HLD, LDL, Lipoprotein(a)), macro- and microvascular complications, ethnicity, family history for diabetes, associated autoimmune diseases (e.g., autoimmune thyroiditis or celiac disease) and mixed meal tolerance test.

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland