Chronic Intestinal InsufficiencyNUPARAGE2NCT07392801
AGE Accumulation in Patients on Long-term Parenteral Nutrition
A study testing Non-invasive skin AGE measurements in people with Chronic Intestinal Insufficiency and Advanced Glycation and Products, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Intestinal Insufficiency, Advanced Glycation and Products, Parenteral Nutrition
- What is being tested?
- Non-invasive skin AGE measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU de Bordeaux-Hôpital des enfants GH Pellegrin
Bordeaux, 33076
Raphaël ENAUD, MD, +335 56 79 98 24, raphael.enaud@chu-bordeaux.fr
Raphaël ENAUD, MD
- Not yet recruiting
AP-HP - Hopital Robert Debré
Paris, 75935
Emmanuelle ECOCHARD-DUGELAY, MD, +331.87.89.16.46, emmanuelle.dugelay@aphp.fr
Emmanuelle ECOCHARD-DUGELAY, MD
- Recruiting
CHU de Bordeaux - Hôpital Haut Lévêque
Pessac, 33600
Florian POULLENOT, MD, +335 57 65 64 40, florian.poullenot@chu-bordeaux.fr
Florian POULLENOT, MD
About this study
Official title: 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.
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.
- Being tested
- Non-invasive skin AGE measurements
- Keywords
- parenteral nutrition, Advanced Glycation End Products, Oxidative Stress, Metabolic Diseases, Cardiovascular Diseases, Short Bowel Syndrome, chronic intestinal insufficiency
- Medical subject headings
- Hyperphagia, Metabolic Diseases, Cardiovascular Diseases, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients starting long-term parenteral nutrition | Other | Observational follow-up of patients starting long-term parenteral nutrition Receives: Other: Non-invasive skin AGE measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin AGE levels
Change in skin AGE levels between baseline and 12 months after initiation of parenteral nutrition (Visit M12).
Measured: Baseline, 12 months
Secondary outcomes (4)
Advanced Glycation End-products
Compare skin AGE (Advanced Glycation End-products) levels with Age levels in parenteral nutrition bags (M6)
Measured: 6 months
Risk factors
Search for risk factors for AGE accumulation linked to dietary habits
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start22 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian POULLENOT, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392801
- Sponsor's protocol ID
- CHUBX 2025/048
- Acronym
- NUPARAGE2
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Advanced Glycation End-products Accumulation in Patients Under Long-Term Parenteral Nutrition (NUPARAGE2)
- ClinicalTrials.gov ID
- NCT07392801
- Acronym / sponsor ID
- NUPARAGE2 / CHUBX 2025/048
- Keywords
- parenteral nutrition, Advanced Glycation End Products, Oxidative Stress, Metabolic Diseases, Cardiovascular Diseases, Short Bowel Syndrome, chronic intestinal insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients starting long-term parenteral nutrition | Other | Other: Non-invasive skin AGE measurementsObservational follow-up of patients starting long-term parenteral nutrition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive skin AGE measurementsNon-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. | Other | Patients starting long-term parenteral nutrition |
Primary outcome
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).
4 secondary outcomes
Advanced Glycation End-products
Time frame: 6 months
Risk factors
Time frame: Baseline, 6 months and 12 months
Skin AGE and metabolic/cardiovascular status
Time frame: Baseline, 6 months and 12 months
AGE and hyperglycaemic episodes
Time frame: Baseline, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian POULLENOT, MD principal investigator
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive skin AGE measurements in people with Chronic Intestinal Insufficiency and Advanced Glycation and Products, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian POULLENOT, MD (+335 57 65 64 40, florian.poullenot@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin AGE levels (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.