AGE Accumulation in Patients on Long-term Parenteral Nutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Non-invasive skin AGE measurements
Other interventionNon-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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients starting long-term parenteral nutritionOther 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
Risk factors
Search for risk factors for AGE accumulation linked to dietary habits
Time frame
Baseline, 6 months and 12 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov