Clinical correlates of persistently elevated liver enzymes in type 2 diabetic outpatients

Giandalia, Annalisa; Romeo, Elisabetta L.; Ruffo, Maria Concetta; Muscianisi, Marco; Giorgianni, Letterio; Forte, F.; Cucinotta, Domenico; Russo, Giuseppina T.

doi:10.1016/j.pcd.2016.12.001

Cited by 13 publications

(12 citation statements)

References 28 publications

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“…For reports such as this to be useful for practicing clinicians, it is essential to put them in context. The prevalence of increased liver enzymes observed here compares to estimates of 10% to 21% in the general population and 12% to 71% in individuals with type 2 diabetes . Comparing results from our study with data concerning the general population is difficult, because the latter may include, for example, individuals with undiagnosed liver pathologies or individuals consuming alcohol in excess of recommended levels.…”

Section: Discussioncontrasting

confidence: 52%

“…The prevalence of increased liver enzymes observed here compares to estimates of 10% to 21% in the general population [15][16][17] and 12% to 71% in individuals with type 2 diabetes. [18][19][20][21] Comparing results from our study with data concerning the general population is difficult, because the latter may include, for example, individuals with undiagnosed liver pathologies or individuals consuming alcohol in excess of recommended levels. We have excluded from our analyses individuals with known liver pathologies and excessive alcohol consumption.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Prevalence of elevated liver enzymes in adults with type 1 diabetes: A multicentre analysis of the German/Austrian DPV database

Stadler

Bollow

Fritsch

et al. 2017

Diabetes Obesity Metabolism

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Section: Discussioncontrasting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Prevalence of elevated liver enzymes in adults with type 1 diabetes: A multicentre analysis of the German/Austrian DPV database

Stadler

Bollow

Fritsch

et al. 2017

Diabetes Obesity Metabolism

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“…The elevated levels of ALT and AST appear in liver function abnormalities. In addition, their measurements are used as biomarkers for diagnosing hepatocellular injuries, since elevation of both ALT and AST levels has been shown in liver-specific damage in T2DM patients [ 26 ]. Subsequently, treatment with herbal extracts reduced the levels of ALT and AST, and blood glucose level was recovered in db/db mice [ 27 ] or patients [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

“…Subsequently, treatment with herbal extracts reduced the levels of ALT and AST, and blood glucose level was recovered in db/db mice [ 27 ] or patients [ 28 ]. Furthermore, complication of impaired liver function was also controlled by TG and TC levels in blood serum [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Anti-hyperglycemic effects and signaling mechanism of Perilla frutescens sprout extract

Kim

Jeong

et al. 2018

Nutr Res Pract

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BACKGROUND/OBJECTIVESPerilla frutescens (L.) Britton var. (PF) sprout is a plant of the labiate family. We have previously reported the protective effects of PF sprout extract on cytokine-induced β-cell damage. However, the mechanism of action of the PF sprout extract in type 2 diabetes (T2DM) has not been investigated. The present study was designed to study the effects of PF sprout extract and signaling mechanisms in the T2DM mice model using C57BL/KsJ-db/db (db/db) mice.MATERIALS/METHODSMale db/db mice were orally administered PF sprout extract (100, 300, and 1,000 mg/kg of body weight) or rosiglitazone (RGZ, positive drug, 1 mg/kg of body weight) for 4 weeks. Signaling mechanisms were analyzed using liver tissues and HepG2 cells.RESULTSThe PF sprout extract (300 and 1,000 mg/kg) significantly reduced the fasting blood glucose, serum insulin, triglyceride and total cholesterol levels in db/db mice. PF sprout extract also significantly improved glucose intolerance and insulin sensitivity, decreased hepatic gluconeogenic protein expression, and ameliorated histological alterations of the pancreas and liver. Levels of phosphorylated AMP-activated protein kinase (AMPK) protein expression also increased in the liver after treatment with the extract. In addition, an increase in the phosphorylation of AMPK and decrease in the phosphoenolpyruvate carboxykinase and glucose 6-phosphatase proteins in HepG2 cells were also observed.CONCLUSIONSOur results sugges that PF sprout displays beneficial effects in the prevention and treatment of type 2 diabetes via modulation of the AMPK pathway and inhibition of gluconeogenesis in the liver.

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“…There are three important pre-analytical ways a lab parameter could be different from the HVRR: physiologically associated with the disease, due to standard of care of the patient population or due to a comorbidity of the patient population. For example, ALT in patients with diabetes, 5 , 8 , 9 increased platelet and neutrophil counts in patients with ulcerative colitis 10 , 11 would be considered physiologically associated with the disease of the patient population. Glucose being higher than the HVRR in patients with schizophrenia is potentially due to the comorbidity of diabetes, since the incidence of diabetes is 2–4 times greater in patients with schizophrenia than in healthy volunteers.…”

Section: Discussionmentioning

confidence: 99%

Are laboratory parameter (biomarker) values similar to the healthy volunteer reference range in all patient populations?

Brott

Goodman

Hermann

et al. 2018

DDDT

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BackgroundLiver biomarkers alanine aminotransferase (ALT) and bilirubin in patients with hepatitis are above the healthy volunteer reference range (HVRR) at baseline (prior to receiving the clinical trial medication). Discussions continue as how to best distinguish drug-induced liver injury in patients with abnormal baseline values participating in clinical trials. This study investigated if other baseline routine clinical safety biomarkers (lab parameters) are different from the HVRR.Materials and methodsClinical trial data (TransCelerate dataset) from placebo and standard of care treated patients were compared to the HVRR using a 10% threshold above or below the HVRR to classify a lab parameter in a patient population as potentially different from the HVRR at baseline. The TransCelerate dataset, batch 4, contained data from patients with Alzheimer’s, asthma, COPD, cardiovascular disease, diabetes, hidradenitis, hypercholesterolemia, rheumatoid arthritis, schizophrenia, stroke, and ulcerative colitis. A subset of the 200 biomarkers in Trans-Celerate were evaluated in this pilot: glucose, platelet count, neutrophil count, ALT, aspartate aminotransferase (AST), and bilirubin.ResultsGlucose was potentially higher than the HVRR in patients with diabetes, COPD, cardiovascular disease, hypercholesterolemia, and schizophrenia. At least one or more of the hematology and hepatic biomarkers were different from the HVRR in at least one patient population, except bilirubin. All the patient populations, except Alzheimer’s and asthma, had at least one biomarker that was higher than the HVRR.SummaryThe routine biomarkers evaluated in this pilot study demonstrated that not all lab parameters in patient populations are similar to the HVRR. Further efforts are needed to determine which biomarkers are different from the HVRR and how to evaluate the biomarkers in patient populations for detecting drug-induced altered lab values in clinical trials.

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Clinical correlates of persistently elevated liver enzymes in type 2 diabetic outpatients

Cited by 13 publications

References 28 publications

Prevalence of elevated liver enzymes in adults with type 1 diabetes: A multicentre analysis of the German/Austrian DPV database

Prevalence of elevated liver enzymes in adults with type 1 diabetes: A multicentre analysis of the German/Austrian DPV database

Anti-hyperglycemic effects and signaling mechanism of Perilla frutescens sprout extract

Are laboratory parameter (biomarker) values similar to the healthy volunteer reference range in all patient populations?

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