Fasting increases serum bilirubin levels in clinically normal, healthy males but not females : a retrospective study from phase I clinical trial participants

Griffin, Paul M., Elliott, Suzanne L., & Manton, Kerry J. (2014) Fasting increases serum bilirubin levels in clinically normal, healthy males but not females : a retrospective study from phase I clinical trial participants. Journal of Clinical Pathology, 67(6), pp. 529-534.

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Abstract

Aim: To examine if fasting affects serum bilirubin levels in clinical healthy males and females.

Methods: We utilised retrospective data from phase 1 clinical trials where blood was collected in either a fed or fasting state at screening and pre-dosing time points and analysed for total bilirubin levels as per standard clinical procedures. Participants were clinically healthy males (n = 105) or females (n = 30) aged 18 to 48 inclusive who participated in a phase 1 clinical trial in 2012 or 2013.

Results: We found a statistically significant increase in total serum bilirubin levels in fasting males as compared to non-fasting males. The fasting time correlated positively with increased bilirubin levels. The age of the healthy males did not correlate with their fasting bilirubin level. We found no correlation between fasting and bilirubin levels in clinically normal females.

Conclusions: The recruitment and screening of volunteers for a clinical trial is a time-consuming and expensive process. This study clearly demonstrates that testing for serum bilirubin should be conducted on non-fasting male subjects. If fasting is required, then participants should not be excluded from a trial based on an elevated serum bilirubin that is deemed non-clinically significant.

Impact and interest:

2 citations in Scopus
2 citations in Web of Science®
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ID Code: 67480
Item Type: Journal Article
Refereed: Yes
Additional Information: Article has been selected for the journal's online learning section.
Additional URLs:
Keywords: Bilirubin, Clinically normal, Clinical trials, Fasting
DOI: 10.1136/jclinpath-2013-202155
ISSN: 1472-4146
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > MEDICAL BIOCHEMISTRY AND METABOLOMICS (110100) > Medical Biochemistry - Amino Acids and Metabolites (110101)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CLINICAL SCIENCES (110300) > Clinical Chemistry (diagnostics) (110302)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CLINICAL SCIENCES (110300) > Pathology (110316)
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2014 by the BMJ Publishing Group Ltd & Association of Clinical Pathologists
Deposited On: 18 Feb 2014 00:42
Last Modified: 18 Apr 2017 23:19

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