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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting long-term parenteral nutrition | Other | Observational follow-up of patients starting long-term parenteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive skin AGE measurements | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin AGE levels | Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12). | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Advanced Glycation End-products | Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6) | 6 months |
| Risk factors | Search for risk factors for AGE accumulation linked to dietary habits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian POULLENOT, MD | Contact | +335 57 65 64 40 | florian.poullenot@chu-bordeaux.fr | |
| Raphaël ENAUD, MD | Contact | +335 56 79 98 24 | raphael.enaud@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florian POULLENOT, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux-Hôpital des enfants GH Pellegrin | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D008659 | Metabolic Diseases |
| D002318 | Cardiovascular Diseases |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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. | 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. | Baseline, 6 months and 12 months |
| AP-HP - Hopital Robert Debré | Paris | 75935 | France |
|
| CHU de Bordeaux - Hôpital Haut Lévêque | Pessac | 33600 | France |
|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |