PKU Clinical Trial
— StressOX-PCUOfficial title:
Antioxidant Signature in Adult Patients With Phenylketonuria (PKU) and Healthy Volunteers : Relationship With Metabolic Disturbances
Verified date | January 2017 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim of the present study is to investigate oxidative stress in PKU with more comprehensive methods.The relationship between oxidative stress and metabolic disturbances (hyperPhenylalaninemia) will also be studied.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - PKU patients over 18 years of age with phenylketonuria not treated with a phenylalanine-controlled diet. - Affiliation to a social security scheme - Reading and signing the informed consent - Control subjects: all healthy subjects over 18 years of unfulfilled abnormal metabolism of whatever nature and associated symptoms Exclusion Criteria: - Pregnancy of patients and control subjects women (confirmed by a negative pregnancy test) - Patients with diseases that may cause oxidative stress (neurodegenerative diseases, cancer) - Patients treated with drugs known to cause oxidative stress - Control subjects:controlled protein diet |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of TOURS | Tours | I&L |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentrations of oxidative stress markers | The main purpose of this preliminary study is to characterize oxidative stress in patients with PKU adults through a comprehensive approach involving the assessment of a wide combination of characteristic markers of oxidative stress and metabolic parameters that may be involved. In this context, we propose to establish an anti-oxidant signing in adult patients PCU using an innovative and comprehensive technical involving Quantification of intraleucocytaire hydrogen peroxide (Evaluated by flow cytometry and is expressed as relative fluorescence intensity between patients and the control group) Study of the expression of 24 genes involved in oxidative stress response (anti-oxydogramme) Comparison nuclear NRF2 translocation Comparison of DNA breaks Quantification of antioxidant vitamins and trace elements.(in difference from Normal values) |
First Day | |
Secondary | Plasma concentrations of amino acids and organic acids concentration | Measurement of concentration of amino acids and organic acids concentration found in the 2 groups in comparison to normal values | First day |
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