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 range18 Years

SexALL

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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

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