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Recruiting NCT06682481

Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function

— Observational Obesity, Childhood Type 2 Diabetes Mellitus in Obese

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of biomarker.
Who it may be relevant to
Registry conditions: Obesity, Childhood, Type 2 Diabetes Mellitus in Obese. Basic parameters: 12 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children

Overview

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.

Interventions

  • Other Measurement of biomarker
    Measurement of blood levels of 1,5-anhydroglucitol

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • University Hospital of Geneva — Geneva

Identifiers

NCT: NCT06682481 · 2024-00031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗