Anhydroglucitol in Children With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594706
• Other study ID #: 2022-01684
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: Philippe Klee
• Phone: +41 22 372 45 90
• Email: philippe.klee[@]unige.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. The values will be compared to those obtained in healthy volunteers. Children with newly diagnosed diabetes as well as children with longstanding disease will be included. 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 type 1 diabetes.

Description:

One-center prospective exploratory pilot 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.

The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with T1DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T1DM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)8.

• Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery (AID).

• Monitoring with a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM).

• Patient willing to keep the same type of CGMS or FGM during the year of observation

• Ability to give informed consent as documented by signature

Exclusion Criteria:

• Patients treated with multiple daily injections (MDI) or not willing to wear a CGMS of FGM

• Patients changing the type of CGMS during the course of the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva	GE

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis	Day 1
Primary	Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis	4 months after diagnosis
Primary	Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis	12 months after diagnosis
Primary	Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration	In participants with a disease duration of 3 years.
Primary	Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration	In participants with a disease duration of 5 years.
Primary	Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass	Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration	In participants with a disease duration of 10 years.