Effect of postprandial state and lipid lowering therapy on serum 7a-C4
Research type
Research Study
Full title
Effect of postprandial state, statins and PCSK9 inhibitors on serum 7a-hydroxy-4-cholesten-3-one concentration
IRAS ID
319475
Contact name
R Gama
Contact email
Sponsor organisation
Royal Wolverhampton NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Bile Acid Diarrhoea (BAD) is a common condition that can have a significant impact on quality of life. Symptoms include diarrhoea, bloating and abdominal pain. Treatment is available for BAD, however diagnostic techniques available are limited, meaning patients often remain undiagnosed. 7aC4 is a marker in blood that may be useful to help diagnose BAD. A method has been developed that can measure 7aC4 in patient blood samples, which may therefore improve diagnosis. In order to bring 7aC4 into routine use, however, assessment of pre-analytical factors that can influence 7aC4 interpretation is important.
Pre-analytical factors that can influence blood test results include, amongst others, time of day the sample is taken, fasting / non-fasting status, medications and storage of the sample prior to analysis. Pre-analytical factors can alter the result of a blood test so that the result does not accurately reflect the concentration of the analyte in the patient. This can cause inappropriate interpretation and mismanagement of the patient.
Literature has suggested both food intake, and lipid lowering medications, can alter 7aC4 concentrations, and this could result in incorrect result interpretation if we do not properly understand the impact of these factors. This study is, therefore, looking at how fasting vs non-fasting can affect 7aC4 concentrations, and whether lipid lowering therapies such as statins and PCSK9 inhibitors can influence 7aC4 concentrations. This will allow us to determine if a fasting sample is required for 7aC4 analysis, and whether caveats are required for patients on lipid lowering therapies.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
22/PR/1372
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion