Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function
Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pierre Maechler
- Email: pierre.maechler@unige.ch
Study Contact Backup
- Name: Philippe Klee
- Phone Number: +41 79 55 33 476
- Email: philippe.klee@unige.ch
Study Locations
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Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1211
- Recruiting
- University Hospital of Geneva
-
Contact:
- Philippe Klee, MD-PhD
- Phone Number: +41 79 55 33 476
- Email: philippe.klee@hcuge.ch
-
Principal Investigator:
- Philippe Klee, MD-PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Measurement of blood levels of 1,5-anhydroglucitol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
|
Second oral glucose tolerance test, 2 years after the first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 2 timepoints
|
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
|
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at 2 timepoints
|
Second oral glucose tolerance test, 2 years after the first
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-00031
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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