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NCT Number: NCT07392801

AGE Accumulation in Patients on Long-term Parenteral Nutrition

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Skin AGE levels

    Time frame: Baseline, 12 months

    Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12).

Secondary outcomes

  1. Advanced Glycation End-products

    Time frame: 6 months

    Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6)

  2. Risk factors

    Time frame: Baseline, 6 months and 12 months

    Search for risk factors for AGE accumulation linked to dietary habits

  3. Skin AGE and metabolic/cardiovascular status

    Time frame: 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.

  4. AGE and hyperglycaemic episodes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Florian POULLENOT, MD

CONTACT

[email protected]

+335 57 65 64 40

Raphaël ENAUD, MD

CONTACT

[email protected]

+335 56 79 98 24

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Study of Advanced Glycation End-products Accumulation in Patients Under Long-Term Parenteral Nutrition (NUPARAGE2)

Acronym: NUPARAGE2

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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