Status:
RECRUITING
Brain Aging in Phenylketonuria
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Phenylketonuria (PKU)
Eligibility:
All Genders
18+ years
Brief Summary
Background: Historically, the primary goal in managing phenylketonuria (PKU) has been to prevent severe and irreversible intellectual disability, as well as to address nutritional deficiencies that co...
Detailed Description
Detailed Research Plan: The investigators' preliminary findings suggest that patients with PKU might show altered aging trajectories compared to controls. The present study will investigate the aging...
Eligibility Criteria
Inclusion
- Patients with PKU
- Participation in PICO-Study and/or:
- PKU diagnosed after a positive newborn screening
- Treatment with Phe-restricted diet starting within the first 30 days of life
- Age ≥18 years
- Written informed consent
Exclusion
- Patients with PKU not following a Phe-restricted diet within 6 months before the study
- Phe concentration above 1600 µmol/L within 6 months before the study
- Concomitant disease states suspected to significantly affect primary or secondary outcomes
- Women who are pregnant or who are breast feeding
- Conditions interfering with MRI such as magnetic (metallic) particles in the skull or brain, cardiac pacemaker, deep brain stimulators, cochlear implant, braces or permanent retainers
- Healthy controls
- Inclusion Criteria:
- Age ≥18 years
- Written informed consent
Key Trial Info
Start Date :
January 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06969209
Start Date
January 13 2025
End Date
August 30 2030
Last Update
May 13 2025
Active Locations (1)
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1
University Hospital Inselspital, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM)
Bern, Switzerland, 3010