How healthy are the “Healthy volunteers”? Penetrance of NAFLD in the biomedical research volunteer pool

Hepatology

Volumn 66, Issue 3, 2017, Pages 825-833

  Takyar, Varun ^a   Nath, Anand ^a,b   Beri, Andrea ^c   Gharib, Ahmed M ^a   Rotman, Yaron ^a  

^a NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^b WASHINGTON HOSPITAL CENTER   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIVER ENZYME; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL;

ADULT; AFRICAN AMERICAN; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BODY MASS; CHOLESTEROL BLOOD LEVEL; CLINICAL PROTOCOL; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DISEASE CLASSIFICATION; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN RESISTANCE; INSULIN SENSITIVITY; LIPID METABOLISM; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; NONALCOHOLIC FATTY LIVER; NORMAL HUMAN; PATIENT SAFETY; PENETRANCE; PRIORITY JOURNAL; REFERENCE VALUE; RETROSPECTIVE STUDY; TRIACYLGLYCEROL BLOOD LEVEL; VALIDITY; CASE CONTROL STUDY; CLASSIFICATION; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; LIVER FUNCTION TEST; MIDDLE AGED; PATHOLOGY; PREDICTIVE VALUE; REPRODUCIBILITY; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; BIOMEDICAL RESEARCH; BODY MASS INDEX; CASE-CONTROL STUDIES; CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; HEALTHY VOLUNTEERS; HUMANS; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; NON-ALCOHOLIC FATTY LIVER DISEASE; PREDICTIVE VALUE OF TESTS; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; RETROSPECTIVE STUDIES; YOUNG ADULT;

EID: 85026307301     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.29247     Document Type: Article

References (43)

1. Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology 2012;142:1592-1609.
2. Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther 2011;34:274-285.
3. Lazo M, Hernaez R, Eberhardt MS, Bonekamp S, Kamel I, Guallar E, et al. Prevalence of nonalcoholic fatty liver disease in the United States: the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Epidemiol 2013;178:38-45.
4. Williams CD, Stengel J, Asike MI, Torres DM, Shaw J, Contreras M, et al. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy: a prospective study. Gastroenterology 2011;140:124-131.
5. Ruhl CE, Everhart JE. Determinants of the association of overweight with elevated serum alanine aminotransferase activity in the United States. Gastroenterology 2003;124:71-79.
6. Chan WK, Tan AT, Vethakkan SR, Tah PC, Vijayananthan A, Goh KL. Non-alcoholic fatty liver disease in diabetics—prevalence and predictive factors in a multiracial hospital clinic population in Malaysia. J Gastroenterol Hepatol 2013;28:1375-1383.
7. Portillo-Sanchez P, Bril F, Maximos M, Lomonaco R, Biernacki D, Orsak B, et al. High prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus and normal plasma aminotransferase levels. J Clin Endocrinol Metab 2015;100:2231-2238.
8. Marcos A, Fisher RA, Ham JM, Olzinski AT, Shiffman ML, Sanyal AJ, et al. Selection and outcome of living donors for adult to adult right lobe transplantation. Transplantation 2000;69:2410-2415.
9. Cimino JJ, Ayres EJ, Remennik L, Rath S, Freedman R, Beri A, et al. The National Institutes of Health's Biomedical Translational Research Information System (BTRIS): design, contents, functionality and experience to date. J Biomed Inform 2014;52:11-27.
10. Prati D, Taioli E, Zanella A, Della Torre E, Butelli S, Del Vecchio E, et al. Updated definitions of healthy ranges for serum alanine aminotransferase levels. Ann Intern Med 2002;137:1-10.
11. Angulo P, Hui JM, Marchesini G, Bugianesi E, George J, Farrell GC, et al. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology 2007;45:846-854.
12. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed December 12, 2016. Published May 28, 2009. Updated June 14, 2010.
13. Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Ann Med 2011;43:617-649.
14. Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA 2012;307:491-497.
15. Li C, Ford ES, McGuire LC, Mokdad AH. Increasing trends in waist circumference and abdominal obesity among US adults. Obesity 2007;15:216-224.
16. Courville AB, DiVito M, Moyer L, Rossinoff A, Royster C, Psota T, et al. Increase in body mass index from normal weight to overweight in a cross-sectional sample of healthy research volunteers. Nutr Res 2014;34:1052-1057.
17. US Census Bureau. American community survey 1-year estimates—census reporter profile page for Washington-Arlington-Alexandria, DC-VA-MD-WV metro area. 2014. Washington, DC: US Federal Government; 2014.
18. Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, et al. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology 2004;40:1387-1395.
19. Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, et al. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol 2011;9:524-530 e1; quiz e60.
20. Dunn W, Xu R, Wingard DL, Rogers C, Angulo P, Younossi ZM, et al. Suspected nonalcoholic fatty liver disease and mortality risk in a population-based cohort study. Am J Gastroenterol 2008;103:2263-2271.
21. Pendino GM, Mariano A, Surace P, Caserta CA, Fiorillo MT, Amante A, et al. Prevalence and etiology of altered liver tests: a population-based survey in a Mediterranean town. Hepatology 2005;41:1151-1159.
22. Suzuki A, Angulo P, Lymp J, St Sauver J, Muto A, Okada T, et al. Chronological development of elevated aminotransferases in a nonalcoholic population. Hepatology 2005;41:64-71.
23. Kotronen A, Yki-Järvinen H, Männistö S, Saarikoski L, Korpi-Hyövälti E, Oksa H, et al. Non-alcoholic and alcoholic fatty liver disease—two diseases of affluence associated with the metabolic syndrome and type 2 diabetes: the FIN-D2D survey. BMC Public Health 2010;10:237.
24. Dunn W, Xu R, Schwimmer JB. Modest wine drinking and decreased prevalence of suspected nonalcoholic fatty liver disease. Hepatology 2008;47:1947-1954.
25. Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, et al. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol 2006;6:33.
26. Ruhl CE, Everhart JE. Fatty liver indices in the multiethnic United States National Health and Nutrition Examination Survey. Aliment Pharmacol Ther 2015;41:65-76.
27. Koliaki C, Roden M. Do mitochondria care about insulin resistance? Mol Metab 2014;3:351-353.
28. Pais R, Giral P, Khan JF, Rosenbaum D, Housset C, Poynard T, et al. Fatty liver is an independent predictor of early carotid atherosclerosis. J Hepatol 2016;65:95-102.
29. Zeb I, Li D, Budoff MJ, Katz R, Lloyd-Jones D, Agatston A, et al. Nonalcoholic fatty liver disease and incident cardiac events: The Multi-Ethnic Study of Atherosclerosis. J Am Coll Cardiol 2016;67:1965-1966.
30. Buechler C, Weiss TS. Does hepatic steatosis affect drug metabolizing enzymes in the liver? Curr Drug Metab 2011;12:24-34.
31. Li P, Robertson TA, Thorling CA, Zhang Q, Fletcher LM, Crawford DH, et al. Hepatic pharmacokinetics of cationic drugs in a high-fat emulsion-induced rat model of nonalcoholic steatohepatitis. Drug Metab Dispos 2011;39:571-579.
32. Canet MJ, Cherrington NJ. Drug disposition alterations in liver disease: extrahepatic effects in cholestasis and nonalcoholic steatohepatitis. Expert Opin Drug Metab Toxicol 2014;10:1209-1219.
33. Barshop NJ, Capparelli EV, Sirlin CB, Schwimmer JB, Lavine JE. Acetaminophen pharmacokinetics in children with nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr 2011;52:198-202.
34. Ferslew BC, Johnston CK, Tsakalozou E, Bridges AS, Paine MF, Jia W, et al. Altered morphine glucuronide and bile acid disposition in patients with nonalcoholic steatohepatitis. Clin Pharmacol Ther 2015;97:419-427.
35. Brill MJ, Diepstraten J, van Rongen A, van Kralingen S, van den Anker JN, Knibbe CA. Impact of obesity on drug metabolism and elimination in adults and children. Clin Pharmacokinet 2012;51:277-304.
36. Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, et al. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015;148:1340-1352 e7.
37. Kaplowitz N, DeLeve L. Drug-Induced Liver Disease- Risk Factors for Drug-Induced Liver Disease. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999.
38. US Food and Drug Administration. Guidance for Industry—Drug-Induced Liver Injury: Premarketing Clinical Evaluation. Washington, DC: US Federal Government; 2009.
39. Kwo PY, Cohen SM, Lim JK. ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Am J Gastroenterol 2017;112:18-35.
40. Dutta A, Saha C, Johnson CS, Chalasani N. Variability in the upper limit of normal for serum alanine aminotransferase levels: a statewide study. Hepatology 2009;50:1957-1962.
41. Siddiqui MS, Sterling RK, Luketic VA, Puri P, Stravitz RT, Bouneva I, et al. Association between high-normal levels of alanine aminotransferase and risk factors for atherogenesis. Gastroenterology 2013;145:1271-1279 e1-3.
42. Blais P, Husain N, Kramer JR, Kowalkowski M, El-Serag H, Kanwal F. Nonalcoholic fatty liver disease is underrecognized in the primary care setting. Am J Gastroenterol 2015;110:10-14.
43. Armstrong MJ, Houlihan DD, Newsome PN. NAFLD is underrecognized in the primary care setting: UK experience. Am J Gastroenterol 2014;109:1500-1501.