CompletedNot Applicable

Study of Low-grade Systemic Inflammation in Adult Patients With Phenylketonuria

France40 participantsStarted 2021-05-26

Plain-language summary

Patient suffering from phenylketonuria have chronic hyperphenylalaninemia. Hyperphenylalaninemia is known to be toxic to central nervous system and cardiovascular system in particular through oxydative stress. In this context, research of low grade systemic inflammation through cytokine assay appears legitimate. The primary outcome of this study is to describe inflammation profile of patients with phenylketonuria.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (patient with PKU) * Age \>/= 18 years old * Phenylketonuria diagnosis * Fasting condition * Registered with a social security system * Patient consent Inclusion Criteria (healthy volunteer) * Age \>/= 18 years old * No metabolic condition * Fasting condition * Paired to patient with phenylketonuria already included according to age, sex and BMI class * Registered with a social security system * Volunteer consent Exclusion Criteria, common to healthy volunteer and patient with phenylketonuria * Pregnant and lactating women * Subject to legal protection measures. * Chronic or acute inflammatory disease * Fever on inclusion * Undergoing anti inflammatory treatment * Surgery in the previous months * Diabetes * Included in other therapeutic trial

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma concentrations of pro-inflammatory cytokines

Timeframe: At the inclusion

Plasma concentrations of CRP

Timeframe: At the inclusion

Trial details

NCT IDNCT04879277

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-25

View on ClinicalTrials.gov More Phenylketonuria trials