Study of Advanced Glycation End-products Accumulation in Patients Under Long-Term Parenteral Nutrition (NUPARAGE2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Skin AGE levels
研究概览
简要总结
This prospective and observational study aims to evaluate the accumulation of advanced glycation end-products (AGEs) in adult and pediatric patients starting long-term parenteral nutrition, by non-invasive skin AGE measurements over a 12-month follow-up.
详细描述
Advanced Glycation End-products (AGEs) result from non-enzymatic glycation of proteins, lipids, or amino acids, and accumulate progressively with age, hyperglycemia, and oxidative stress. Their accumulation is associated with metabolic and cardiovascular complications in chronic diseases. Preliminary data suggest that patients on long-term parenteral nutrition may experience increased AGE accumulation due to high intravenous glucose exposure. However, prospective data evaluating AGE kinetics from the initiation of parenteral nutrition are lacking.
Skin AGE levels will be measured non-invasively at baseline, 6 months, and 12 months using the AGE Reader© device. Nutrition bag samples will be analyzed for AGE content via HPLC-MS.
Patients will be monitored during routine consultations every 6 months. Biological metabolic parameters (HbA1c, fructosamine, lipid profile), nutritional data, and 3-day dietary records will be collected at each time point. Samples from parenteral nutrition bags will be frozen at -20°C or colder and analyzed centrally after the last patient visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (adults and children, all ages) initiating long-term parenteral nutrition
- •Followed at CHU de Bordeaux or Robert Debré Hospital (APHP)
- •Covered by French Social Security system
- •Written informed consent obtained from patient (if adult) or legal guardian (if minor)
排除标准
- •Fitzpatrick skin type ≥ V (darker skin tones)
- •Forearm tattoos at the site of measurement
- •For patients included under 1 year of age: patients born prematurely (before 37 weeks of amenorrhea)
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Patients starting long-term parenteral nutrition
Observational follow-up of patients starting long-term parenteral nutrition
干预措施: Non-invasive skin AGE measurements (Other)
结局指标
主要结局
Skin AGE levels
时间窗: Baseline, 12 months
Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12).
次要结局
- Advanced Glycation End-products(6 months)
- Risk factors(Baseline, 6 months and 12 months)
- Skin AGE and metabolic/cardiovascular status(Baseline, 6 months and 12 months)
- AGE and hyperglycaemic episodes(Baseline, 6 months and 12 months)