Advanced Glycation and Products, Chronic Intestinal Insufficiency, Parenteral Nutrition
Conditions
Keywords
parenteral nutrition, Advanced Glycation End Products, Oxidative Stress, Metabolic Diseases, Cardiovascular Diseases, Short Bowel Syndrome, chronic intestinal insufficiency
Brief summary
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
OTHERNon-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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin AGE levels | Baseline, 12 months | Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced Glycation End-products | 6 months | Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6) |
| Risk factors | Baseline, 6 months and 12 months | Search for risk factors for AGE accumulation linked to dietary habits |
| Skin AGE and metabolic/cardiovascular status | Baseline, 6 months and 12 months | To investigate whether there is an association between skin AGE levels and the metabolic and cardiovascular status of patients. |
| AGE and hyperglycaemic episodes | Baseline, 6 months and 12 months | To investigate whether there is an association between skin AGE levels and the number, duration and intensity of hyperglycaemic episodes during parenteral nutrition infusion. |
Countries
France
Contacts
CONTACTFlorian POULLENOT, MD
CONTACTRaphaël ENAUD, MD
PRINCIPAL_INVESTIGATORFlorian POULLENOT, MD
University Hospital, Bordeaux
Outcome results
None listed