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Mechanisms of Type 1 Diabetes Endophenotypes (METYDIA)

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ClinicalTrials.gov Identifier: NCT05764850
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Collaborators:
University Hospital, Geneva
University of Geneva, Switzerland
Information provided by (Responsible Party):
Pediatric Clinical Research Platform

Study Description
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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.


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Genetic Predisposition to Disease Genetic: Genome sequencing

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Group/Cohort Intervention/treatment
Case
100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort
 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.

Other Names:
  • Lipidomic
  • Metabolomic
  • Transcriptomic
  • Mixed meal tolerance test
Control
50 control patients
 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.

Other Names:
  • Lipidomic
  • Metabolomic
  • Transcriptomic
  • Mixed meal tolerance test


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   0 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05764850


Contacts
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Contact: Valerie VS Schwitzgebel, MD +41 22 372 45 90 valerie.schwitzgebel@unige.ch
Contact: Fanny FL Iafrate-Luterbacher, MD +41 78 603 06 92 fanny.luterbacher@hcuge.ch

Locations
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Switzerland
University Hospital of Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Valerie VS Schwitzgebel, MD    +41 22 372 45 90    valerie.schwitzgebel@unige.ch   
Contact: Fanny FL Iafrate Luterbacher, MD    +41 78 603 06 92    fanny.luterbacher@hcuge.ch   
Principal Investigator: Valerie VS Schwitzgebel, MD         
Sub-Investigator: Fanny FL Iafrate Luterbacher, MD         
Sponsors and Collaborators
Pediatric Clinical Research Platform
University Hospital, Geneva
University of Geneva, Switzerland
Investigators
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Principal Investigator: Valerie VS Schwitzgebel, MD University Hospital of Geneva / University of Geneva
More Information
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Responsible Party: Pediatric Clinical Research Platform
ClinicalTrials.gov Identifier: NCT05764850    
Other Study ID Numbers: 2022-02119
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pediatric Clinical Research Platform:
Type 1 diabetes mellitus
Children
Adolescent
Young adult
Genetic
 Transcriptomic
Metabolomic
Lipidomic
Genetic risk score
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Genetic Predisposition to Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Disease Susceptibility
Disease Attributes
Pathologic Processes