Type 1 Diabetes MellitusMETYDIANCT05764850
Mechanisms of Type 1 Diabetes Endophenotypes
An observational study of Type 1 Diabetes Mellitus and Genetic Predisposition to Disease, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 0 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Genetic Predisposition to Disease
- What is being tested?
- Genome sequencing
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2023to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Informed consent as documented by signature
- Patient's age: between 0 and 25 years old.
- Children, adolescents, and young adult patients followed in diabetology.
- 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
Who cannot join
- No exclusion criteria
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, 1205
Valerie VS Schwitzgebel, MD, +41 22 372 45 90, valerie.schwitzgebel@unige.ch
Fanny FL Iafrate Luterbacher, MD, +41 78 603 06 92, fanny.luterbacher@hcuge.ch
About this study
Official title: Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis
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.
- Being tested
- Genome sequencing
- Keywords
- Type 1 diabetes mellitus, Children, Adolescent, Young adult, Genetic, Transcriptomic, Metabolomic, Lipidomic, Genetic risk score
- Medical subject headings
- Diabetes Mellitus, Type 1, Genetic Predisposition to Disease, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome sequencingGenetic
Also called Lipidomic, Metabolomic, Transcriptomic, Mixed meal tolerance test
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.
| Study group | Role | What they receive |
|---|---|---|
| Case | 100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort Receives: Genetic: Genome sequencing | |
| Control | 50 control patients Receives: Genetic: Genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: blood sampling and analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Valerie VS Schwitzgebel, MD, Principal investigator, University Hospital of Geneva / University of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764850
- Sponsor's protocol ID
- 2022-02119
- Acronym
- METYDIA
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis
- ClinicalTrials.gov ID
- NCT05764850
- Acronym / sponsor ID
- METYDIA / 2022-02119
- Keywords
- Type 1 diabetes mellitus, Children, Adolescent, Young adult, Genetic, Transcriptomic, Metabolomic, Lipidomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Geneva, Switzerland
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Genetic: Genome sequencing100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort |
| Control | – | Genetic: Genome sequencing50 control patients |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- Informed consent as documented by signature
- Patient's age: between 0 and 25 years old.
- Children, adolescents, and young adult patients followed in diabetology.
- Informed consent as documented by signature
- Patient's age: 25 less than 6 years of age and 25 between 6 and 25 years old.
Key exclusion criteria (3 listed)
- No exclusion criteria
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genome sequencingAlso: Lipidomic, Metabolomic, Transcriptomic, Mixed meal tolerance test100 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. | Genetic | Case, Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie VS Schwitzgebel, MD principal investigator
University Hospital of Geneva / University of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Genetic Predisposition to Disease, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie VS Schwitzgebel, MD (+41 22 372 45 90, valerie.schwitzgebel@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cluster analysis to decipher underlying mechanisms of type 1 diabetes (time frame: blood sampling and analyses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.