The Sapienza University Mortality and Morbidity Events Rate (SUMMER) Study in Diabetes: Identification of New Molecular Promoters of Mortality and Morbidity in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,139
- 试验地点
- 1
- 主要终点
- Number of all-cause deaths
研究概览
简要总结
This observational study is aimed at identifying new molecular promoters of mortality (and morbidity) in patients with type 2 diabetes mellitus (T2DM).
详细描述
Background Mortality rate of diabetic patients is about twice as much that of non-diabetic individuals of similar age; this makes diabetes a leading risk factor for mortality, especially of cardiovascular origin, which accounts for 2.9 million global events yearly. Such scenario is expected to further deteriorate, given that the prevalence of type 2 diabetes mellitus (T2DM), by far the most common form of diabetes comprising more than 90% of all diabetic individuals, is increasing worldwide. Predicting such devastating event is, therefore, urgently needed in order to target aggressive prevention strategies in high risk T2DM patients.
Aims This observational study is aimed at identifying new molecular promoters of all-cause mortality in patients with T2DM.
Secondary endpoints are to identify in these individuals molecular markers of
- cardiovascular mortality;
- myocardial infarction;
- stroke;
- dialysis.
Other pre-specified endpoints are to assess in these subjects:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
排除标准
- •Severe psychiatric illnesses
- •End-stage renal disease and dialysis
- •Cirrhosis
- •Any active cancer
结局指标
主要结局
Number of all-cause deaths
时间窗: 5 years
Number of participants who die for all causes and time of occurrence of such events
次要结局
- Number of cardiovascular deaths(5 years)
- Number of subjects with myocardial infarction(5 years)
- Number of subjects entering dialysis(5 years)
- Number of subjects with stroke(5 years)
研究者
Vincenzo Trischitta
MD, Professor of Endocrinology
University of Roma La Sapienza