AGE Accumulation in Patients on Long-term Parenteral Nutrition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive skin AGE measurements.
- Who it may be relevant to
- Registry conditions: Chronic Intestinal Insufficiency, Advanced Glycation and Products, Parenteral Nutrition. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Advanced Glycation End-products Accumulation in Patients Under Long-Term Parenteral Nutrition (NUPARAGE2)
Overview
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.
Detailed description
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.
Interventions
- Other Non-invasive skin AGE measurements
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.
Primary outcome measures
- Skin AGE levels [Time frame: Baseline, 12 months]
Secondary outcome measures (4)
- Advanced Glycation End-products [Time frame: 6 months]
- Risk factors [Time frame: Baseline, 6 months and 12 months]
- Skin AGE and metabolic/cardiovascular status [Time frame: Baseline, 6 months and 12 months]
- AGE and hyperglycaemic episodes [Time frame: Baseline, 6 months and 12 months]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- CHU de Bordeaux-Hôpital des enfants GH Pellegrin — Bordeaux
- AP-HP - Hopital Robert Debré — Paris
- CHU de Bordeaux - Hôpital Haut Lévêque — Pessac
Identifiers
NCT: NCT07392801 · CHUBX 2025/048