Mechanisms of Type 1 Diabetes Endophenotypes

Type 1 Diabetes Mellitus Clinical Trial

— METYDIA  

Official title:

Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764850
• Other study ID #: 2022-02119
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2023
• Source: Pediatric Clinical Research Platform
• Contact: Valerie VS Schwitzgebel, MD
• Phone: +41 22 372 45 90
• Email: valerie.schwitzgebel[@]unige.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 25 Years

Eligibility

Inclusion Criteria (Type 1 Diabetic patients):

• Informed consent as documented by signature

• Patient's age: between 0 and 25 years old.

• Children, adolescents, and young adult patients followed in diabetology.

Exclusion Criteria (Type 1 Diabetic patients):

• No exclusion criteria

Inclusion Criteria (Controls):

• Informed consent as documented by signature

• Patient's age: 25 less than 6 years of age and 25 between 6 and 25 years old.

• Healthy patient

Exclusion Criteria (Controls):

• Patient receiving treatment affecting metabolic control (ex: systemic corticoids, beta blocker, immunotherapy etc.)

• Concomitant disease that may affect the analysis of the results (ex: cancer, active autoimmune disease requiring treatment)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Genetic Predisposition to Disease
• Type 1 Diabetes Mellitus

Intervention

Genetic:
• Genome sequencing
100 extensively phenotyped pediatric and young adult patients for genotyping, metabolomic and lipidomic analyses. Polygenic risk scores for type 1 diabetes and cardiovascular disease will be performed. For patients older than 6 years who agree to do a second visit (optional), a Mixed Meal Tolerance Test (MMTT: the gold standard for assessing beta cell function) will be done as well as transcriptomic analysis.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Pediatric Clinical Research Platform	University Hospital, Geneva, University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cluster analysis to decipher underlying mechanisms of type 1 diabetes	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.	blood sampling and analyses