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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
Non-invasive skin AGE measurements at baseline, 6 and 12 months; collection and analysis of parenteral nutrition bag samples; routine metabolic assessments; dietary records, glucose holter, plasma glycated hemoglobin and fructosamine assays.
CHU de Bordeaux-Hôpital des enfants GH Pellegrin
Bordeaux, France
NOT_YET_RECRUITINGAP-HP - Hopital Robert Debré
Paris, France
NOT_YET_RECRUITINGCHU de Bordeaux - Hôpital Haut Lévêque
Pessac, France
RECRUITINGSkin AGE levels
Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12).
Time frame: Baseline, 12 months
Advanced Glycation End-products
Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6)
Time frame: 6 months
Risk factors
Search for risk factors for AGE accumulation linked to dietary habits
Time frame: Baseline, 6 months and 12 months
Skin AGE and metabolic/cardiovascular status
To investigate whether there is an association between skin AGE levels and the metabolic and cardiovascular status of patients.
Time frame: Baseline, 6 months and 12 months
AGE and hyperglycaemic episodes
To investigate whether there is an association between skin AGE levels and the number, duration and intensity of hyperglycaemic episodes during parenteral nutrition infusion.
Time frame: Baseline, 6 months and 12 months
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