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Clinical Trial Summary

This study will assess the cardiovascular disease (CVD) risk in Phenylketonuria (PKU) patients on a low-phenylalanine diet (LPD).

Ultrasound tests, diet information and routine blood samples will be collected once per patient at their next outpatient appointment.

32 adults with PKU will be studied and compared to reference data for healthy people. The results will show if the PKU CVD risk differs from healthy people, and if CVD risk varies within people with PKU.


Clinical Trial Description

Cardiovascular disease (CVD) is the largest cause of deaths worldwide each year. Many factors affect CVD including diet, genetics, exercise and smoking. It is unclear if Phenylketonuria (PKU) and the low-phenylalanine diet (LPD) affect CVD risk.

CVD risk can be predicted by measuring the thickness of the artery wall in the neck which supplies blood to the head. Thickness is measured using a non-invasive, safe ultrasound test (similar to pregnancy jelly scans). A wall thicker than normal indicates an increased CVD risk. A wall thinner than normal indicates a lower CVD risk. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04251494
Study type Observational
Source Guy's and St Thomas' NHS Foundation Trust
Contact Radha Ramachandran
Phone 02071880848
Email Radha.Ramachandran@gstt.nhs.uk
Status Recruiting
Phase
Start date February 23, 2019
Completion date April 22, 2021

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