DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Type 2 Diabetes occurrence
研究概览
简要总结
The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.
详细描述
Type 2 diabetes (T2D) is a real public health issue, with an exponential incidence. Before its diagnosis, several physiopathological changes are already taking place, such as insulin resistance of target tissues and the progressive inability of pancreatic beta cells to produce insulin. The objective of this study is a better understanding of the prediabetic stage and mechanisms involved in the possible development of T2D, by way of a five-year follow-up cohort study in 207 prediabetic subjects.
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
- •Previous history (within 2 months prior to enrollment visit) of fasting blood glucose ≥ 1,10 g/l and < 1,26 g/l OR fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.
排除标准
- •Fasting glycemia ≥ 1.26 g/l
- •History of treatment with oral antidiabetics
- •History of treatment with insulin, except gestational diabetes
- •Subject with any history or presence of significant hematologic (coagulation, thrombopenia, …), hepatic, renal, or psychiatric disorders
- •Subject unable to follow the study during the 5 years of follow-up
- •Subject in exclusion period of a previous study or simultaneously participating to any other clinical trial on metabolism
结局指标
主要结局
Type 2 Diabetes occurrence
时间窗: 5 years (or less if occurrence of the condition)
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 pre-diabetes in North of France(5 years)
- HbA1c measurement(5 years)
- Diabetes Risk Score(5 years)
- Others cardiovascular risk factors(5 years)
- Biomarkers(7 to 10 years)