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. and 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: 529-534. doi:10.1136/jclinpath-2013-202155


Author Griffin, Paul M.
Elliott, Suzanne L.
Manton, Kerry J.
Title Fasting increases serum bilirubin levels in clinically normal, healthy males but not females: a retrospective study from phase I clinical trial participants
Journal name Journal of Clinical Pathology   Check publisher's open access policy
ISSN 1472-4146
0021-9746
Publication date 2014-06
Year available 2014
Sub-type Article (original research)
DOI 10.1136/jclinpath-2013-202155
Open Access Status
Volume 67
Issue 6
Start page 529
End page 534
Total pages 6
Place of publication London, United Kingdom
Publisher BMJ Group
Collection year 2015
Language eng
Formatted abstract
Aim To examine if fasting affects serum bilirubin levels in clinically healthy males and females.

Methods We used retrospective data from phase I clinical trials where blood was collected in either a fed or fasting state at screening and predosing 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 18–48 inclusive who participated in a phase I clinical trial in 2012 or 2013.

Results We found a statistically significant increase in total serum bilirubin levels in fasting males as compared with 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.
Keyword Fasting
Serum bilirubin levels
Clinical trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Medicine Publications
 
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