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Article ; Online: Advances in noninvasive measurement of liver function and physiology: The HepQuant DuO test.

McRae, Michael P / Kittelson, John / Helmke, Steve M / Everson, Gregory T

Basic & clinical pharmacology & toxicology

2024 Volume 134, Issue 3, Page(s) 385–395

Abstract: Current noninvasive liver tests are surrogates for fibrosis and lack ability to directly measure liver function. HepQuant tests measure liver function and physiology through hepatic uptake of stable cholate isotopes. HepQuant SHUNT (V1.0) involves oral ... ...

Abstract	Current noninvasive liver tests are surrogates for fibrosis and lack ability to directly measure liver function. HepQuant tests measure liver function and physiology through hepatic uptake of stable cholate isotopes. HepQuant SHUNT (V1.0) involves oral and intravenous dosing and six blood samples over 90 min. We developed simplified test versions: SHUNT V2.0 (oral and intravenous dosing, two blood samples over 60 min) and DuO (oral dosing only, two blood samples over 60 min). The aim of this study was to evaluate equivalency of the simplified tests to the original SHUNT test. Data from three studies comprising 930 SHUNT tests were retrospectively analysed by each method. Equivalence was evaluated in terms of proportion of tests in which the difference between methods was less than any clinically meaningful difference and additionally by two one-sided t-test and bioequivalence methods. DuO and SHUNT V2.0 were equivalent to the original SHUNT test for Disease Severity Index, with >99% and >96% of tests falling within equivalence bounds. DuO and SHUNT V2.0 met equivalency criteria by two one-sided t-tests and bioequivalence. DuO and SHUNT V2.0 are easier to administer, are less invasive than the original SHUNT test and have potential to be more accepted by patients and providers.
MeSH term(s)	Humans ; Retrospective Studies ; Liver ; Liver Cirrhosis/diagnosis ; Liver Function Tests ; Therapeutic Equivalency
Language	English
Publishing date	2024-01-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2134679-3
ISSN	1742-7843 ; 1742-7835
ISSN (online)	1742-7843
ISSN	1742-7835
DOI	10.1111/bcpt.13980
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Article ; Online: Within-individual reproducibility of a dual sample oral cholate challenge test (DuO) and simplified versions of the HepQuant SHUNT test.

McRae, Michael P / Kittelson, John / Helmke, Steve M / Everson, Gregory T

Clinical and translational science

2024 Volume 17, Issue 4, Page(s) e13786

Abstract: Current noninvasive liver tests measure fibrosis, inflammation, or steatosis and do not measure function. The HepQuant platform of noninvasive tests uniquely assesses both liver function and physiology through the hepatic uptake of stable isotopes of ... ...

Abstract	Current noninvasive liver tests measure fibrosis, inflammation, or steatosis and do not measure function. The HepQuant platform of noninvasive tests uniquely assesses both liver function and physiology through the hepatic uptake of stable isotopes of cholate. However, the prototypical HepQuant SHUNT test (SHUNT V1.0) is cumbersome to administer, requiring intravenous and oral administration of cholate and six peripheral venous blood samples over 90 min. To alleviate the burden of test administration, we explored whether an oral only (DuO) version, and other simplified versions, of the test could provide reproducible measurements of liver function. DuO requires only oral dosing and two blood samples over 60 min. The simplified SHUNT test versions were SHUNT V1.1 (oral and IV dosing but four blood samples) and SHUNT V2.0 (oral and IV dosing but only two blood samples over 60 min). In this paper, we describe the reproducibility of DuO and the simplified SHUNT tests relative to that of SHUNT V1.0; equivalency is described in a separate paper. Data from two studies comprising 236 SHUNT tests in 94 subjects were analyzed retrospectively by each method. All simplified methods were highly reproducible across test parameters with intraclass correlation coefficients >0.93 for test parameters Disease Severity Index (DSI) and Hepatic Reserve. DuO and SHUNT V2.0 improved reproducibility in measuring portal-systemic shunting (SHUNT%). These simplified tests, particularly DuO and SHUNT V2.0, are easier to administer and less invasive, thus, having the potential to be more widely accepted by care providers administering the test and by patients receiving the test.
MeSH term(s)	Humans ; Reproducibility of Results ; Retrospective Studies ; Liver Function Tests ; Liver ; Cholates
Chemical Substances	Cholates
Language	English
Publishing date	2024-04-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13786
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Article ; Online: Hepatic Dysfunction Quantified by HepQuant DuO Outperforms Child-Pugh Classification in Predicting the Pharmacokinetics of Ampreloxetine.

Kanodia, Jitendra / Giovinazzo, Hugh / Yates, Wayne / Bourdet, David L / McRae, Michael P / Helmke, Steve M / Everson, Gregory T

Clinical pharmacology and therapeutics

2024

Abstract: HepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child-Pugh ... ...

Abstract	HepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child-Pugh classification to categorize the degree of hepatic dysfunction. We compared HepQuant tests with Child-Pugh classification in predicting the pharmacokinetics of ampreloxetine. Twenty-one subjects with hepatic impairment (8 Child-Pugh A, 7 Child-Pugh B, and 6 Child-Pugh C), and 10 age- and sex-matched controls were studied. The pharmacokinetics of ampreloxetine were measured after oral administration of a single dose of 10 mg. Disease severity index (DSI), portal-systemic shunting (SHUNT%), hepatic reserve, and hepatic filtration rates (HFRs) were measured from serum samples obtained after intravenous administration of [24-
Language	English
Publishing date	2024-04-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3265
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Article ; Online: Compartmental model describing the physiological basis for the HepQuant SHUNT test.

McRae, Michael P / Helmke, Steve M / Burton, James R / Everson, Gregory T

Translational research : the journal of laboratory and clinical medicine

2022 Volume 252, Page(s) 53–63

Abstract: The HepQuant SHUNT test quantifies hepatic functional impairment from the simultaneous clearance of cholate from the systemic and portal circulations for the purpose of monitoring treatment effects or for predicting risk for clinical outcome. ... ...

Abstract	The HepQuant SHUNT test quantifies hepatic functional impairment from the simultaneous clearance of cholate from the systemic and portal circulations for the purpose of monitoring treatment effects or for predicting risk for clinical outcome. Compartmental models are defined by distribution volumes and transfer rates between volumes to estimate parameters not defined by noncompartmental analyses. Previously, a noncompartmental analysis method, called the minimal model (MM), demonstrated reproducible and reliable measures of liver function (Translational Research 2021). The aim of this study was to compare the reproducibility and reliability of a new physiologically based compartmental model (CM) vs the MM. Data were analyzed from 16 control, 16 nonalcoholic steatohepatitis (NASH), and 16 hepatitis C virus (HCV) subjects, each with 3 replicate tests conducted on 3 separate days. The CM describes transfer of cholates between systemic, portal, and liver compartments with assumptions from measured or literature-derived values and unknown parameters estimated by nonlinear least-squares regression. The CM was compared to the MM for 6 key indices of hepatic disease in terms of intraclass correlation coefficient (ICC) with a lower acceptable limit of 0.7. The CM correlated well with the MM for disease severity index (DSI) with R
MeSH term(s)	Humans ; Epidemiological Models ; Reproducibility of Results ; Liver ; Non-alcoholic Fatty Liver Disease ; Liver Function Tests ; Cholates
Chemical Substances	Cholates
Language	English
Publishing date	2022-08-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2246684-8
ISSN	1878-1810 ; 1532-6543 ; 1931-5244
ISSN (online)	1878-1810 ; 1532-6543
ISSN	1931-5244
DOI	10.1016/j.trsl.2022.08.002
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Article ; Online: Dynamic Elevation of Aromatic Amino Acids in Hepatitis C Virus-Induced Cirrhosis After a Standard Meal.

Hill, Kareen L / Haddad, James A / Ali, Rabab O / Zhang, Grace Y / Quinn, Gabriella M / Townsend, Elizabeth / Everson, Gregory T / Helmke, Steve M / Bagheri, Mohammadhadi / Schoenfeld, Megan / Yang, Shanna / Koh, Christopher / Levy, Elliot B / Kleiner, David E / Sacks, David B / Etzion, Ohad / Heller, Theo

Clinical and translational gastroenterology

2024 Volume 15, Issue 3, Page(s) e00666

Abstract: Introduction: Perturbations in aromatic (AAAs) and branched-chain amino acids (BCAAs) are seen in decompensated liver disease. The aim of this study was to evaluate the dynamic, postprandial relationship between hepatitis C virus-induced liver disease ... ...

Abstract	Introduction: Perturbations in aromatic (AAAs) and branched-chain amino acids (BCAAs) are seen in decompensated liver disease. The aim of this study was to evaluate the dynamic, postprandial relationship between hepatitis C virus-induced liver disease and amino acid concentrations in patients with compensated liver disease. Methods: Patients infected with hepatitis C virus underwent a baseline liver biopsy to determine Ishak Fibrosis Score and evaluate the liver transcriptome. Patients ate a standard meal and underwent peripheral vein sampling at defined intervals. Quantitative analysis of amino acids was performed using liquid chromatography-tandem mass spectrometry. Results: At baseline, there was no difference in AAA and BCAA concentrations between patients with cirrhosis and non-cirrhotic patients. After a standard meal, AAAs, but not BCAAs, were elevated in patients with cirrhosis compared with non-cirrhotic patients at every time point. The HepQuant SHUNT fraction was significantly higher in patients with cirrhosis and positively correlated with AAA concentration at all time points, but not BCAA. Analysis of the hepatic transcriptome demonstrated greater downregulation of the AAA degradation pathways than the BCAA degradation pathways. Discussion: At baseline, cirrhotic patients with compensated liver disease have adequate reserve liver function to metabolize AAAs and BCAAs. When faced with a metabolic stressor, such as a standard meal, patients with cirrhosis are less able to metabolize the increased load of AAAs. This impairment correlates with portosystemic shunting. Further evaluation of AAA levels in compensated liver disease might further the understanding of the liver-muscle axis and the role it may play in the development of sarcopenia in liver disease.
MeSH term(s)	Humans ; Amino Acids, Aromatic ; Hepacivirus/genetics ; Liver Cirrhosis/etiology ; Liver Cirrhosis/metabolism ; Amino Acids ; Amino Acids, Branched-Chain ; Liver Diseases ; Hepatitis C/complications
Chemical Substances	Amino Acids, Aromatic ; Amino Acids ; Amino Acids, Branched-Chain
Language	English
Publishing date	2024-03-01
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2581516-7
ISSN	2155-384X ; 2155-384X
ISSN (online)	2155-384X
ISSN	2155-384X
DOI	10.14309/ctg.0000000000000666
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Article ; Online: Somatostatin, estrogen, and polycystic liver disease.

Everson, Gregory T / Helmke, Steve M

Gastroenterology

2013 Volume 145, Issue 2, Page(s) 279–282

MeSH term(s)	Cysts/drug therapy ; Female ; Humans ; Liver/pathology ; Liver Diseases/drug therapy ; Male ; Polycystic Kidney, Autosomal Dominant/drug therapy ; Somatostatin/analogs & derivatives
Chemical Substances	Somatostatin (51110-01-1)
Language	English
Publishing date	2013-08
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	80112-4
ISSN	1528-0012 ; 0016-5085
ISSN (online)	1528-0012
ISSN	0016-5085
DOI	10.1053/j.gastro.2013.06.025
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Article ; Online: HepQuant SHUNT Detects Portal Hypertension in Early Stages of Clinically Compensated Chronic Liver Disease.

Wieland, Amanda / Etzion, Ohad / Ali, Rabab O / Levy, Elliot / Kleiner, David E / Helmke, Steve M / Heller, Theo / Everson, Gregory T

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

2021 Volume 20, Issue 4, Page(s) e890–e894

Abstract: Physicians use portal pressure measurements in clinical practice and research but the methods are invasive, can cause complications, and are resource intensive. ...

Abstract	Physicians use portal pressure measurements in clinical practice and research but the methods are invasive, can cause complications, and are resource intensive.
MeSH term(s)	Humans ; Hypertension, Portal/complications ; Liver Cirrhosis/complications ; Liver Cirrhosis/diagnosis ; Liver Cirrhosis/surgery
Language	English
Publishing date	2021-04-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2119789-1
ISSN	1542-7714 ; 1542-3565
ISSN (online)	1542-7714
ISSN	1542-3565
DOI	10.1016/j.cgh.2021.04.030
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Article: Measurement of the NO metabolites, nitrite and nitrate, in human biological fluids by GC-MS.

Helmke, Steve M / Duncan, Mark W

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2007 Volume 851, Issue 1-2, Page(s) 83–92

Abstract: In this article we critically review the development and application of gas chromatography-mass spectrometry (GC-MS) techniques to the measurement of the nitric oxide (NO) metabolites, nitrite and nitrate, in human biological fluids. Our focus is on the ... ...

Abstract	In this article we critically review the development and application of gas chromatography-mass spectrometry (GC-MS) techniques to the measurement of the nitric oxide (NO) metabolites, nitrite and nitrate, in human biological fluids. Our focus is on the issue of the fitness of any analytical strategy to its intended purpose and the validity of the analytical results generated. The accuracy, precision, recovery, selectivity and sensitivity of the various methods are evaluated and the potential pitfalls, both specific to the methods, and general to the area, are considered. Several examples of the applications of these techniques to clinical investigations of NO physiology are also critically evaluated.
MeSH term(s)	Body Fluids/chemistry ; Gas Chromatography-Mass Spectrometry/methods ; Humans ; Nitrates/analysis ; Nitric Oxide/analysis ; Nitrites/analysis ; Reproducibility of Results
Chemical Substances	Nitrates ; Nitrites ; Nitric Oxide (31C4KY9ESH)
Language	English
Publishing date	2007-05-15
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	1570-0232
ISSN	1570-0232
DOI	10.1016/j.jchromb.2006.09.047
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Article: Proteomics of the anterior pituitary gland as a model for studying the physiology of a heterogeneous organ.

Blake, Charles A / Helmke, Steve M

Experimental biology and medicine (Maywood, N.J.)

2005 Volume 230, Issue 11, Page(s) 793–799

Abstract: The anterior pituitary gland (AP) secretes six established hormones that collectively control hundreds of biological and behavioral functions. Because of advances in mass spectrometry (MS), protein labeling, and bioinformatics, it is now possible to ... ...

Abstract	The anterior pituitary gland (AP) secretes six established hormones that collectively control hundreds of biological and behavioral functions. Because of advances in mass spectrometry (MS), protein labeling, and bioinformatics, it is now possible to characterize, compare, and quantify the AP hormones together with large numbers of nonhormonal AP proteins. For example, by using high-performance liquid chromatography in line with tandem MS we characterized 145 proteins in sub-cellular fractions of the AP of young adult male Golden Syrian hamsters and 115 proteins in subcellular fractions of the AP of young adult male mice. These included hormones, proteins involved in hormone synthesis and release, and housekeeping proteins. We also used difference gel electrophoresis in conjunction with MS and peptide mass fingerprinting to quantify the effects of estrogen on the AP-soluble protein fraction in rats. Ovariectomized rats were administered 50 microg of estradiol valerate subcutaneously and studied 48 hrs later, before the onset of the anticipated surges of gonadotropins in blood. Following DeCyder image analysis, we identified by MS and peptide mass fingerprinting 26 protein spots that were upregulated and 19 protein spots that were downregulated. Estrogen increased levels of acidic isoforms of growth hormone and prolactin, several proteins involved in protein synthesis, folding and secretion, and several metabolic enzymes. Most of the downregulated proteins are involved in RNA or DNA interactions. We followed up on the results with RT-PCR and immunohistochemical techniques to demonstrate that one protein identified by MS in hamster AP, fertility protein SP22, is synthesized in the AP and localized primarily in somatotropes and thyrotropes. These experiments demonstrate the efficacy of our proteomics approach to characterize AP proteins and quantify changes in them. The approaches used to study the AP could serve as a model to investigate other heterogeneous organs.
MeSH term(s)	Animals ; Cricetinae ; DNA-Binding Proteins/metabolism ; Estradiol/administration & dosage ; Female ; Gene Expression Regulation/drug effects ; Gene Expression Regulation/physiology ; Gonadotropins/blood ; Male ; Mice ; Microtubule-Associated Proteins/metabolism ; Pituitary Gland, Anterior/physiology ; Pituitary Hormones, Anterior/metabolism ; Proteome/physiology ; Proteomics ; RNA-Binding Proteins/metabolism ; Rats
Chemical Substances	DNA-Binding Proteins ; Gonadotropins ; Microtubule-Associated Proteins ; Pituitary Hormones, Anterior ; Proteome ; RNA-Binding Proteins ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2005-12-06
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Review
ISSN	1535-3702
ISSN	1535-3702
DOI	10.1177/153537020523001103
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Article ; Online: Advances in management of polycystic liver disease.

Everson, Gregory T / Helmke, Steve M / Doctor, Brian

Expert review of gastroenterology & hepatology

2008 Volume 2, Issue 4, Page(s) 563–576

Abstract: The focus of this review is polycystic liver disease, a genetic disorder characterized by multiple macroscopic liver cysts that initially bud from biliary epithelium but subsequently lack communication with the biliary tree. There are two main clinical ... ...

Abstract	The focus of this review is polycystic liver disease, a genetic disorder characterized by multiple macroscopic liver cysts that initially bud from biliary epithelium but subsequently lack communication with the biliary tree. There are two main clinical presentations: polycystic liver associated with autosomal dominant polycystic kidney disease and isolated polycystic liver disease. Both of these forms of polycystic liver disease exhibit an autosomal dominant pattern of inheritance. Clinical manifestations of polycystic liver disease are related to either mass effect of the volume of hepatic cysts or to complications arising within the cysts. Polycystic liver disease rarely progresses to hepatic failure or clinical complications of portal hypertension. Management is directed at counseling patients and families, treating complications and reducing cyst load by surgical techniques: cyst fenestration, hepatic resection or, rarely, hepatic transplantation. Recent research suggests that blockade of cyst secretion or inhibition of epithelial cells might be useful in halting progression of disease--these observations are discussed in this review.
MeSH term(s)	Cysts/complications ; Cysts/genetics ; Cysts/therapy ; Disease Progression ; Humans ; Liver Diseases/complications ; Liver Diseases/genetics ; Liver Diseases/therapy ; Liver Transplantation ; Mutation ; Polycystic Kidney, Autosomal Dominant/complications ; Radiotherapy
Language	English
Publishing date	2008-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2481021-6
ISSN	1747-4132 ; 1747-4124
ISSN (online)	1747-4132
ISSN	1747-4124
DOI	10.1586/17474124.2.4.563
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