NCT05764850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

February 16, 2023

Last Update Submit

February 28, 2023

Conditions

Type 1 Diabetes MellitusGenetic Predisposition to Disease

Keywords

Type 1 diabetes mellitusChildrenAdolescentYoung adultGeneticTranscriptomicMetabolomicLipidomicGenetic risk score

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Case

100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort

Genetic: Genome sequencing

Control

50 control patients

Genetic: Genome sequencing

Interventions

Genome sequencingGENETIC

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.

Also known as: Lipidomic, Metabolomic, Transcriptomic, Mixed meal tolerance test
CaseControl

Eligibility Criteria

Age0 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children, adolescents, and young adults followed at the pediatric diabetology unit of the University Hospital of Geneva. Controls Children, adolescents, and young adults coming for a routine blood sample at University Hospital of Geneva

You may qualify if:

  • Informed consent as documented by signature
  • Patient's age: between 0 and 25 years old.
  • Children, adolescents, and young adult patients followed in diabetology.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Genetic Predisposition to DiseaseGenetic Risk Score

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Valerie VS Schwitzgebel, MD

    University Hospital of Geneva / University of Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie VS Schwitzgebel, MD

CONTACT

+41 22 372 45 90valerie.schwitzgebel@unige.ch

Fanny FL Iafrate-Luterbacher, MD

CONTACT

+41 78 603 06 92fanny.luterbacher@hcuge.ch

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 13, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)