ClinicalTrials.gg
RecruitingNCT07392801NUPARAGE2Updated Jul 24, 2026

AGE Accumulation in Patients on Long-term Parenteral Nutrition

An interventional study of Non-invasive skin AGE measurements in Chronic Intestinal Insufficiency, Advanced Glycation and Products and Parenteral Nutrition, sponsored by University Hospital, Bordeaux. Recruiting at 3 sites in France. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 55 studies in Metabolic Diseases with a site in France — 17 open to participants now, 22 under way, 6 of them phase 3. Metabolic Diseases · France.

Planned enrollment
25th of 38
50 · median 79
Started
2026
with 3 others
No phase
14 of 55
3 open now
Primary completion
2027-07
later than 7 of 21 live
Registered
53rd of 55
by date

Among the 55 studies in Metabolic Diseases with a site in France, this one is the 25th largest by planned enrollment of the 38 interventional ones that give a count, is one of 4 that started in 2026, is one of 14 with no phase, reaches primary completion later than 7 of the 21 other live ones, and was the 53rd registered.

Metabolic Diseases

763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.

Browse Metabolic Diseases studies →

Open to participants now

17 of the 55 studies in Metabolic Diseases with a site in France are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 133 Metabolic Diseases studies recruiting now, 47 (35%) set no upper age limit and 63 (47%) stop at 75 or younger; 38 take children under 18; 50 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Chronic Intestinal Insufficiency
  • Advanced Glycation and Products
  • Parenteral Nutrition

Keywords

  • parenteral nutrition
  • Advanced Glycation End Products
  • Oxidative Stress
  • Metabolic Diseases
  • Cardiovascular Diseases
  • Short Bowel Syndrome
  • chronic intestinal insufficiency
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained from patient (if adult) or legal guardian (if minor)

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Patients starting long-term parenteral nutrition

    Observational follow-up of patients starting long-term parenteral nutrition

    Other: Non-invasive skin AGE measurements

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.

06

What researchers measure

Primary outcomes

  1. Skin AGE levels

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

    Time frame: Baseline, 12 months

Secondary outcomes

  1. Advanced Glycation End-products

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

    Time frame: 6 months

  2. Risk factors

    Search for risk factors for AGE accumulation linked to dietary habits

    Time frame: Baseline, 6 months and 12 months

  3. 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.

    Time frame: Baseline, 6 months and 12 months

  4. 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.

    Time frame: Baseline, 6 months and 12 months

07

Study locations

1 of 3 sites recruiting
  • CHU de Bordeaux-Hôpital des enfants GH Pellegrin
    Bordeaux, 33076, France
    Not yet recruiting
  • AP-HP - Hopital Robert Debré
    Paris, 75935, France
    Not yet recruiting
    • Emmanuelle ECOCHARD-DUGELAY, MD · Contactemmanuelle.dugelay@aphp.fr · +331.87.89.16.46
    • Emmanuelle ECOCHARD-DUGELAY, MD · Principal investigator
  • CHU de Bordeaux - Hôpital Haut Lévêque
    Pessac, 33600, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.

Of 182 non-industry interventional studies with no phase under Metabolic Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's planned 12 months is below that.

Counting every sponsor, half of 201 studies reached it within 22 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2026
First posted
Feb 6, 2026
StartActual
Jul 22, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2028
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07392801
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Jul 22, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jul 24, 2026

Study contacts

Florian POULLENOT, MD
Contact
florian.poullenot@chu-bordeaux.fr
+335 57 65 64 40
Raphaël ENAUD, MD
Contact
raphael.enaud@chu-bordeaux.fr
+335 56 79 98 24
Florian POULLENOT, MD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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