Ruolo Del Marcatore TMEM219 in Corso di Diabete di Tipo 1
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
- Altered TMEM219 expression in pancreatic islets/beta cells in diabetes.
研究概览
简要总结
Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes.
The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.
详细描述
METHODS OF RECRUITING THE SUBJECTS Healthy subjects, individuals with type 1 and type 2 diabetes and those who are at risk of developing diabetes will be enrolled. Enrollment was approved by the University of Florida Ethics Committee within the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.
Duration of the study: 5 years.
EXPERIMENTAL PROCEDURE:
The following analyses will be performed on the collected and received samples:
- Study of TMEM219 expression and of other TMEM219-related markers by immunohistochemistry and immunofluorescence and western blot
- Study of TMEM219 expression and of other TMEM219-related markers by molecular biology analysis
- Analysis of the proteomic profile on collected biological liquids The above analyses will be performed at the Pediatric Clinical Research Center Romeo ed Enrica Invernizzi at the Sacco Hospital - University of Milan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reported in the NPOD protocol
排除标准
- •Reported in the NPOD protocol
结局指标
主要结局
Altered TMEM219 expression in pancreatic islets/beta cells in diabetes.
时间窗: 1-24 months
Change of TMEM219 expression in pancreatic islets/beta cells of healthy subjects as compared to that of individuals with type 1 diabetes (T1D), with type 2 diabetes (T2D) and of those at risk for developing the disease.
次要结局
- Increased beta cell loss due to a dysregulated TMEM219 signaling in diabetes.(25 months-48 months)
- Altered TMEM219-peripheral regulating factors in diabetes.(49 months-60 months)
研究者
Paolo Fiorina, MD
Professor of Endocrinogy University of Milan, Director of Endocrinology and Diabetology Unit ASST Fatebenefratelli-Sacco
University of Milan