Obesity, ChildhoodNCT06682481
Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function
An observational study of Obesity, Childhood and Type 2 Diabetes Mellitus in Obese, run by Philippe Klee, MD-PhD at 1 site in Switzerland.
Trial summary
The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity, Childhood, Type 2 Diabetes Mellitus in Obese
- What is being tested?
- Measurement of biomarker
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Nov 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 16 years
- All sexes
- Child
Study population: 50 obese children aged 12 to 16 years who have a normal or altered glucose metabolism.
Who may be able to join
- Children aged 12 to 16 years
- Obesity. Defined as a body-mass index above the 97th percentile.
- Ability to give informed consent as documented by signature
Who cannot join
- Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
- Patients with known liver disease (other than NAFLD)
- Patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion.
- Patients treated with a drug known to affect liver function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre Maechler contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, Canton of Geneva, 1211
Philippe Klee, MD-PhD, +41 79 55 33 476, philippe.klee@hcuge.ch
Philippe Klee, MD-PhD
About this study
Official title: Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children
The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.
Read the detailed description
One-center prospective study performed in collaboration between the Pediatric Endocrine and Diabetology unit of the University Hospitals of Geneva (HUG) and Prof. Pierre Maechler, Diabetes Center of the Faculty of Medicine, University of Geneva Switzerland.
1,5-anhydroglucitol (1,5-AG), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. The decline of this biomarker precedes the development of hyperglycemia in lean b-Phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms.
Additional studies have shown a correlation of 1,5-AG levels with risk of progression of type 1 diabetes (T1DM) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes (T2DM).
The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with obesity with or without T2DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T2DM.
- Being tested
- Measurement of biomarker
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of biomarkerOther
Measurement of blood levels of 1,5-anhydroglucitol
| Study group | Role | What they receive |
|---|---|---|
| Children with obesity | Children with obesity followed within the pediatric endocrine and diabetes unit of the University Hospitals of Geneva, Switzerland. The investigators will do prospective measures in 50 children aged 12 to 15 years, at the time of a planned oral glucose tolerance test and again, 2 years later. Receives: Other: Measurement of biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
Measured: First oral glucose tolerance test
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
Measured: Second oral glucose tolerance test, 2 years after the first
Secondary outcomes (2)
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at 2 timepoints
Measured: First oral glucose tolerance test
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at 2 timepoints
Measured: Second oral glucose tolerance test, 2 years after the first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippe Klee, MD-PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor-investigator, Philippe Klee, MD-PhD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682481
- Sponsor's protocol ID
- 2024-00031
- Status last verified
- May 2026
- First submitted
- 7 Nov 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children
- ClinicalTrials.gov ID
- NCT06682481
- Acronym / sponsor ID
- 2024-00031
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Philippe Klee, MD-PhDUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Nov 2024 (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 investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.
Detailed description
One-center prospective study performed in collaboration between the Pediatric Endocrine and Diabetology unit of the University Hospitals of Geneva (HUG) and Prof. Pierre Maechler, Diabetes Center of the Faculty of Medicine, University of Geneva Switzerland.
1,5-anhydroglucitol (1,5-AG), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. The decline of this biomarker precedes the development of hyperglycemia in lean b-Phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms.
Additional studies have shown a correlation of 1,5-AG levels with risk of progression of type 1 diabetes (T1DM) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes (T2DM).
The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with obesity with or without T2DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with obesity | – | Other: Measurement of biomarkerChildren with obesity followed within the pediatric endocrine and diabetes unit of the University Hospitals of Geneva, Switzerland. The investigators will do prospective measures in 50 children aged 12 to 15 years, at the time of a planned oral glucose tolerance test and again, 2 years later. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- 50 obese children aged 12 to 16 years who have a normal or altered glucose metabolism.
Key inclusion criteria (3 listed)
- Children aged 12 to 16 years
- Obesity. Defined as a body-mass index above the 97th percentile.
- Ability to give informed consent as documented by signature
Key exclusion criteria (4 listed)
- Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
- Patients with known liver disease (other than NAFLD)
- Patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion.
- Patients treated with a drug known to affect liver function
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 |
|---|---|---|
| Measurement of biomarkerMeasurement of blood levels of 1,5-anhydroglucitol | Other | Children with obesity |
Primary outcome
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Time frame: First oral glucose tolerance test
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Time frame: Second oral glucose tolerance test, 2 years after the first
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
2 secondary outcomes
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Time frame: First oral glucose tolerance test
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Time frame: Second oral glucose tolerance test, 2 years after the first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
Pierre Maechler contact
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 Obesity, Childhood and Type 2 Diabetes Mellitus in Obese, run by Philippe Klee, MD-PhD 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Klee (+41 79 55 33 476, philippe.klee@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control (time frame: First oral glucose tolerance test). The study lists 2 primary outcomes in all. 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 18 May 2026.