IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population
研究概览
简要总结
The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years)
- •Subjects with diabetes risk score ≥ 15
- •Subjects with impaired fasting glucose: blood glucose ≥ 1.10 g/l and < 1 .26 g/L
- •Subjects affiliated with an appropriate social security system
排除标准
- •Fasting glycemia ≥ 1.26 g/l
- •Fasting glycemia ≤ 1.10 g/l
- •Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists.
- •Subjects previously treated with insulin, except gestational diabetes
- •Severe coagulation disorders
- •Thrombocytopenia < 100 000/mm 3
- •Severe psychiatric disorders
- •Severe renal insufficiency (creatinine clearance < 30 ml/min)
- •Severe hepatic insufficiency (TP < 50%)
- •Alcohol abuse (> 30g/j)
- •Patient's opposition
- •Subject unable to follow the study during the 5 years of follow-up
- •Subject exclusion period in a previous study
结局指标
主要结局
The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population
时间窗: 10 years
The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population
次要结局
- Number of patients with high Diabetes Risk Score and pre-diabetes(10 years)
- Number of patients with others cardiovascular risk factors(10 years)
- HbA1c measurement(10 years)
- Number of patients with pre-diabetes(10 years)
- Relation between "working hours and conditions" and metabolic disease(10 years)