Measuring a new biomarker in obese children with or without type 2 diabetes
Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children
University Hospital, Geneva · NCT06682481
This study is testing a new blood marker in obese kids aged 12 to 16, with and without type 2 diabetes, to see if it can help understand how their bodies manage sugar.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva (other) |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT06682481 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure blood levels of 1,5-anhydroglucitol in obese children aged 12 to 16 years, both with and without type 2 diabetes. The researchers will correlate these levels with functional beta-cell mass and glucose metabolism parameters, comparing them to healthy volunteers. The goal is to validate 1,5-anhydroglucitol as a novel biomarker for assessing beta-cell function in this population. The study is conducted at the University Hospital of Geneva in collaboration with the Diabetes Center of the Faculty of Medicine, University of Geneva.
Who should consider this trial
Good fit: Ideal candidates are obese children aged 12 to 16 years who do not have autoimmune diabetes.
Not a fit: Patients with known liver disease or those treated with certain diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for early detection and monitoring of beta-cell dysfunction in obese children, potentially improving management of type 2 diabetes.
How similar studies have performed: Previous studies have shown correlations between 1,5-anhydroglucitol levels and diabetes progression, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Geneva, Canton of Geneva
- University Hospital of Geneva — Geneva, Canton of Geneva, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Philippe Klee
- Email: philippe.klee@unige.ch
- Phone: +41 79 55 33 476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Childhood, Type 2 Diabetes Mellitus in Obese