Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)
- •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
排除标准
- •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.
研究组 & 干预措施
Newly diagnosed patients with T1DM
The investigators will do prospective measures in 10 to 15 children aged 2 to 18 years, at the time of diagnosis, four months after diagnosis and one year after diagnosis.
干预措施: Measurement of blood levels of 1,5-anhydroglucitol (Other)
Patients with T1DM of different duration
As the functional beta-cell mass gradually declines as disease duration increases, the investigators will do measurements in a cohort of children aged ≤ 18 years, with increasing diabetes duration. The investigators plan to analyze groups of 5 patients with a disease duration of 3 (36 - 47 months), 5 (60 - 71 months) and 10 years (120 - 131 months), respectively.
干预措施: Measurement of blood levels of 1,5-anhydroglucitol (Other)
结局指标
主要结局
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
时间窗: 12 months after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
时间窗: In participants with a disease duration of 10 years.
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
时间窗: Day 1
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
时间窗: 4 months after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
时间窗: In participants with a disease duration of 3 years.
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
时间窗: In participants with a disease duration of 5 years.
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
次要结局
未报告次要终点
研究者
Philippe Klee, MD-PhD
Principal investigator
University Hospital, Geneva