NCT07392801

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

January 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 29, 2026

Last Update Submit

April 30, 2026

Conditions

Chronic Intestinal InsufficiencyParenteral NutritionAdvanced Glycation and Products

Keywords

parenteral nutritionAdvanced Glycation End ProductsOxidative StressMetabolic DiseasesCardiovascular DiseasesShort Bowel Syndromechronic intestinal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Skin AGE levels

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

    Baseline, 12 months

Secondary Outcomes (4)

  • Advanced Glycation End-products

    6 months

  • Risk factors

    Baseline, 6 months and 12 months

  • Skin AGE and metabolic/cardiovascular status

    Baseline, 6 months and 12 months

  • AGE and hyperglycaemic episodes

    Baseline, 6 months and 12 months

Study Arms (1)

Patients starting long-term parenteral nutrition

OTHER

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

Other: Non-invasive skin AGE measurements

Interventions

Non-invasive skin AGE measurementsOTHER

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.

Patients starting long-term parenteral nutrition

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Bordeaux-Hôpital des enfants GH Pellegrin

Bordeaux, 33076, France

Location

AP-HP - Hopital Robert Debré

Paris, 75935, France

Location

CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, 33600, France

Location

MeSH Terms

Conditions

HyperphagiaMetabolic DiseasesCardiovascular DiseasesShort Bowel Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutritional and Metabolic DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic Processes

Study Officials

  • Florian POULLENOT, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian POULLENOT, MD

CONTACT

+335 57 65 64 40florian.poullenot@chu-bordeaux.fr

Raphaël ENAUD, MD

CONTACT

+335 56 79 98 24raphael.enaud@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(3)