Advanced Glycation Products and the Incidence of Vascular Complications in Type 1 Diabetes: DIABAGE Study After More Than 5 Years
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Association between baseline AGE values and incident cases of vascular complications.
研究概览
简要总结
DIABAGE (Diabetes Advanced Glycation End products) study was conducted between 2015 and 2017. It included 196 type 1 diabetic patients with more than 10 years of diabetes. It revealed a significant association between the occurrence of vascular complications and tissular Advanced Glycation End products (AGEs) as well as with some circulating AGEs. This protocol is a continuation of that initial research.
详细描述
The objective is to evaluate in patients included in the DIABAGE study the incident vascular events (micro and macroangiopathic) after at least 5 years of follow-up.
The secondary objectives are:
- To assess the predictive value of the initial measurement of AGEs (Advanced Glycation End Products) on the occurrence of these complications.
- To study the correlation between tissue AGEs measured after 5 years of evolution and HbA1c values between the first inclusion and this new evaluation.
Material and Methods:
Experimental design: monocentric observational study (Reims University Hospital).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion in initial DIABAGE study.
- •Follow-up at Reims hospital.
排除标准
- •Refusal to participate.
结局指标
主要结局
Association between baseline AGE values and incident cases of vascular complications.
时间窗: At inclusion
* Occurrence of a cardiovascular event. * Appearance or aggravation of ophthalmological involvement. * Appearance or worsening of diabetic nephropathy. * Appearance of diabetic neuropathy.
次要结局
- The correlation between the tissue AGE deltas (defined by the difference between the AGEs at 5 years and the initial AGEs) and the cumulative HbA1c over the 5 years.(At inclusion)
- The association between baseline AGE values and the occurrence of macrovascular damage.(At inclusion)