DIabetes REsearCh on Patient straTification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,049
- 主要终点
- Glycemic deterioration
研究概览
简要总结
The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).
详细描述
There are two multicentre prospective cohort studies within the glycaemic deterioration work package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (Study 1) and in those who have recently been diagnosed with the disease (Study 2).
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
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination
- •Management by lifestyle with or without metformin therapy
- •All HbA1c <7.6% (<60 mmol/mol) within previous 3 months
- •White European
- •Age ≥35 and <75
- •Estimated GFR >50 ml/min'
排除标准
- •Type 1 diabetes
- •A previous HbA1c >9.0% (>75 mmol/mol)
- •Prior treatment with insulin or an oral hypoglycaemic agent other than metformin
- •BMI <20 or >50 kg/m2
- •Pregnancy, lactation or plans to conceive within the study period
- •Any other significant medical reason for exclusion as determined by the investigator
结局指标
主要结局
Glycemic deterioration
时间窗: Up to 10 years follow-up
Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin
次要结局
未报告次要终点