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Clinical Trials/NCT05764850
NCT05764850
Recruiting
Not Applicable

Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis

Pediatric Clinical Research Platform1 site in 1 country150 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Pediatric Clinical Research Platform
Enrollment
150
Locations
1
Primary Endpoint
Cluster analysis to decipher underlying mechanisms of type 1 diabetes
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
February 1, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pediatric Clinical Research Platform
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cluster analysis to decipher underlying mechanisms of type 1 diabetes

Time Frame: 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.

Study Sites (1)

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