Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
研究概览
简要总结
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.
详细描述
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.
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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter
- •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
结局指标
主要结局
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
时间窗: 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
次要结局
- Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis(Second oral glucose tolerance test, 2 years after the first)
研究者
Philippe Klee, MD-PhD
Principal Investigator
University Hospital, Geneva