AGE Accumulation in Patients on Long-term Parenteral Nutrition (NUPARAGE2)

April 30, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux-Hôpital des enfants GH Pellegrin
        • Principal Investigator:
          • Raphaël ENAUD, MD
        • Contact:
      • Paris, France, 75935
        • AP-HP - Hopital Robert Debré
        • Contact:
        • Principal Investigator:
          • Emmanuelle ECOCHARD-DUGELAY, MD
      • Pessac, France, 33600
        • CHU de Bordeaux - Hôpital Haut Leveque
        • Principal Investigator:
          • Florian POULLENOT, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients starting long-term parenteral nutrition
Observational follow-up of patients starting long-term parenteral nutrition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced Glycation End-products
Time Frame: 6 months
Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6)
6 months
Risk factors
Time Frame: Baseline, 6 months and 12 months
Search for risk factors for AGE accumulation linked to dietary habits
Baseline, 6 months and 12 months
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.
Baseline, 6 months and 12 months
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.
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Florian POULLENOT, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2025/048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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