Distribution of Fibrosis-4 index and vibration-controlled transient elastography-derived liver stiffness measurement for patients with metabolic dysfunction-associated steatotic liver disease in health check-up.

AIMS: The multisociety consensus nomenclature has introduced steatotic liver disease (SLD) with diverse subclassifications, which are metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD), alcohol-associated liver disease (ALD), specific etiology, and cryptogenic. We investigated their prevalence, as per the new definition, in individuals undergoing health check-ups. Additionally, we analyzed the distribution of Fibrosis-4 (FIB-4) index and vibration-controlled transient elastography (VCTE)-derived liver stiffness measurement (LSM) for MASLD. METHODS: In this cross-sectional study, 6530 subjects undergoing a health check-up in Japan were included. Conventional B-mode ultrasound was carried out on all 6530 subjects, and those with MASLD underwent VCTE. RESULTS: The prevalence of SLD was 39.5%, comprising MASLD 28.7%, MetALD 8.6%, ALD 1.2%, specific etiology SLD 0.3%, and cryptogenic SLD 0.7%. Subjects with VCTE-derived LSM ≥8 kPa constituted 2.1% of MASLD. FIB-4 ≥1.3 showed that the sensitivity, specificity, positive predictive value (PPV), and negative predictive value for diagnosing VCTE-derived LSM ≥8 kPa were 60.6%, 77.0%, 5.3%, and 98.9%, respectively. The referral rate to specialists was 23.8% using FIB-4 ≥1.30. "FIB-4 ≥1.3 in subjects <65 years and FIB-4 ≥2.0 in subjects ≥65 years" showed higher PPV (6.7%) and lower referral rate (17.1%) compared with FIB-4 ≥1.3, but the sensitivity (54.5%) did not show adequate diagnostic capability as a noninvasive test for diagnosing VCTE-derived LSM ≥8 kPa. CONCLUSIONS: Acknowledging the selection bias in hepatology centers, we undertook this prospective health check-up study. Although the FIB-4 index proves to be a convenient marker, it might not perform well as a primary screening tool for liver fibrosis in the general population (UMIN Clinical Trials Registry No. UMIN000035188).

Screening for compensated advanced chronic liver disease using transient elastography in outpatient addiction clinics.

BACKGROUND: Patients with substance use disorders present with many risk factors for liver disease-including alcohol, hepatitis C virus infection, and obesity-and should thus be screened for compensated advanced chronic liver disease (cACLD). Such screening could potentially be performed by outpatient addiction clinics. In this study, we aimed to assess the feasibility, acceptability, and results of cACLD screening using transient elastography (TE) among all patients attending routine follow-up visits at addiction clinics, regardless of their liver disease risk factors. METHODS: Liver fibrosis evaluation using TE was offered to every patient consulting two different addiction clinics in France, between December 2020 and September 2021, during dedicated half-day screening sessions. The screening was proposed during the patient's routine care and was performed immediately after the scheduled consultation. Patients with a liver stiffness measurement over 8 kPa were referred to a hepatology visit in the addiction clinic within 2-4 weeks. RESULTS: Screening was offered to 227 patients and was accepted by 116 (51%) patients. Twelve patients had a liver stiffness over 8 kPa, and nine of these patients attended the recommended specialist hepatology visit. Five patients (4.3% of those screened) were diagnosed with cACLD. Patients' acceptance of the screening was associated with older age, being on one's own or professionally inactive, and presenting with alcohol use disorder. CONCLUSION: Overall, our results demonstrated that opportunistic cACLD screening using TE in outpatient addiction clinics was feasible and acceptable, with good results.

Use of transient elastography for hepatic steatosis and fibrosis evaluation in patients with subclinical hypothyroidism.

Objective: To evaluate the association between subclinical hypothyroidism and hepatic steatosis and fibrosis using the noninvasive diagnostic methods transient hepatic elastography (TE) and controlled attenuation parameter (CAP) in patients with subclinical hypothyroidism. Subjects and methods: This was a cross-sectional study including women with confirmed spontaneous subclinical hypothyroidism and an age- and body mass index (BMI)-matched control group without thyroid disease or circulating antithyroperoxidase (anti-TPO) antibodies. Exclusion criteria were age > 65 years, thyroid-stimulating hormone (TSH) > 10.0 mIUI/L, BMI ≥ 35 kg/m2, diabetes, or other chronic liver diseases. Liver stiffness was classified according to TE values (in kPa) and ranged from absence of fibrosis (F0) to advanced fibrosis (F3). Hepatic steatosis was classified according to CAP values (in dB/m) and ranged from low-grade (S1) to advanced (S3) steatosis. Results: Of 68 women enrolled, 27 were included in the subclinical hypothyroidism group and 41 in the control group. Advanced steatosis (S3) was more frequent in the subclinical hypothyroidism group (25.9% versus 7.3%, respectively, p = 0.034). Circulating anti-TPO was an independent factor associated with advanced steatosis (odds ratio 9.5, 95% confidence interval 1.3-68.3). In multiple linear regression analysis, TE values (which evaluated fibrosis) correlated negatively with free thyroxine levels. Conclusion: The results of this study strengthen the hypothesis that hepatic steatosis is associated with autoimmune (positive anti-TPO) subclinical hypothyroidism, independently from BMI. However, subclinical hypothyroidism alone does not appear to be associated with a significantly increased risk of hepatic fibrosis.

Impact of Comorbid Polycystic Ovary Syndrome on Clinical and Laboratory Parameters in Female Adolescents with Metabolic Dysfunction-Associated Steatotic Liver Disease: A Cross-Sectional Study.

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) and polycystic ovary syndrome (PCOS) share several pathophysiological mechanisms. While the prevalence of MASLD has been extensively studied in PCOS populations, the occurrence of PCOS among female adolescents with transient elastography (TE)-confirmed MASLD in pediatric hepatology settings remains poorly characterized. This cross-sectional study aims to address this knowledge gap and elucidate potential clinical and biochemical differences between female adolescents with MASLD and comorbid PCOS compared to those without PCOS. Methods: The study cohort included 45 female adolescents with TE-diagnosed MASLD. Comparative analyses of clinical and laboratory parameters were performed between those with (n = 19) and those without (n = 26) comorbid PCOS, diagnosed according to the Rotterdam criteria. Results: Adolescents with MASLD and comorbid PCOS exhibited significantly higher weight, lower height, and increased waist circumference compared to those without PCOS. Additionally, the prevalence of acanthosis nigricans was significantly higher in the PCOS group (68.4% versus 34.6%, p = 0.025). Regarding laboratory parameters, serum phosphorus levels and liver enzymes-including aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyl transferase-were significantly lower in adolescents with comorbid PCOS. However, no significant differences were observed in lipid profiles, glucose metabolism, or novel non-invasive biomarkers of MASLD. Conclusions: This study reveals distinct clinical and biochemical profiles in female adolescents with MASLD and comorbid PCOS compared to those without PCOS. These findings have the potential to inform and refine future screening protocols and diagnostic algorithms for these interrelated conditions, specifically tailored to pediatric hepatology settings.

Transient Elastography for Noninvasive Evaluation of Posttransplant Liver Graft Fibrosis in Turkish Children, Ege University Children Hospital Experience.

OBJECTIVES: The influence of advancing fibrosis on graft survival in the context of pediatric liver transplantation accentuates the critical role of protocol-driven liver biopsies, a practice adopted by numerous medical centers. Consequently, the exigency for noninvasive methodologies to assess graft fibrosis assumes heightened importance when conventional clinical and laboratory parameters fail to reveal signs of liver damage. METHODS: This study aimed to assess the reliability of transient elastography (TE) in pediatric liver transplant recipients to detect graft fibrosis and compare the results of TE in patients who underwent biopsy. RESULTS: This prospective cohort study included liver transplanted children who underwent biopsy at Ege University Children's Hospital between October 1, 2021, and October 31, 2022, and a healthy control group. According to TE, fibrosis was detected in 40 patients, and no fibrosis was detected in 50. The median time to develop fibrosis was 100 months (95% CI [83.1-116.8]). A statistically significant positive correlation existed between LSM and METAVIR fibrosis score (r = 0.562, p = 0.001). There was a statistically significant difference in LSM between patients with F2 fibrosis (7.8-8.8 kPa ± 3.2) compared to patients with F0 fibrosis (5.2 kPa ± 0.7) (p = 0.005) and F1 fibrosis (6.1 kPa ± 1.5) (p = 0.041), on ANOVA. CONCLUSION: Liver allograft fibrosis is common in long-term follow-up in children who have undergone liver transplantation. Abnormal TE may guide physicians to consider liver biopsy to detect late allograft fibrosis in these children.

The association analysis between exposure to volatile organic compounds and fatty liver disease in US Adults.

BACKGROUND: Limited epidemiological research has explored the associations between ambient volatile organic compounds (VOCs) and fatty liver disease (FLD). This study aimed to explore the associations between VOCs and FLD and liver function biomarkers. We obtained urinary concentrations of VOCs metabolites from NHANES. METHODS: Weighted logistic regression models were employed to investigate the relationships between VOCs and FLD risk, including alcoholic FLD (AFLD) and non-alcoholic FLD (NAFLD). The associations of VOCs and liver function biomarkers were also investigated using weighted linear regression. RESULTS: Among the 2050 participants, 774 were classified as having FLD. After adjustment, each log-transformed SD increase in N-Acetyl-S-(2-carboxyethyl)-l-cysteine (CEMA), 2-Aminothiazoline-4-carboxylicacid (ATCA), and trans-trans-muconic-acid (MUCA) had a OR (95%CI) of 1.30 (1.06-1.61; P-trend=0.014), 1.34 (1.12-1.61; P-trend=0.002), and 1.22 (1.01-1.47; P-trend=0.035), respectively. ATCA and MUCA were associated with higher risks of NAFLD (OR=1.47, 95%CI: 1.20-1.79, and OR=1.26, 95%CI: 1.02-1.56, respectively). VOCs were positively associated with gamma glutamyl transaminase (GGT) and C-reactive protein (CRP), while inversely associated with albumin, total protein and alanine aminotransferase (ALT) (P < 0.05). CONCLUSIONS: Urinary metabolites of VOCs have been found to be strongly correlated with a higher risk of FLD and NFALD, and impaired liver function. These novel findings merit further prospective studies to comprehend the effect of VOCs on liver diseases.

Comparing imaging modalities in the assessment of fibrosis in metabolic dysfunction-associated steatotic liver disease.

BACKGROUND: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease in children. Liver biopsy is considered the gold standard for diagnosis. Magnetic resonance elastography (MRE) and transient elastography (TE) are imaging modalities that can monitor fibrosis and steatosis noninvasively. More studies are needed to identify whether imaging modalities can provide accurate and reproducible data. We hypothesize that MRE provides reliable data similar to that of TE when compared to liver biopsy in children with MASLD/metabolic dysfunction-associated steatohepatitis. METHODS: We conducted a retrospective chart review of children with liver biopsy-proven MASLD at Children's Hospital Los Angeles between September 2017 and January 2023, investigating and comparing the predictive accuracy of MRE and TE in the detection of high-grade fibrosis on liver biopsy. RESULTS: Seventy-seven patients were reviewed, all of whom had undergone liver biopsy, MRE and TE for evaluation of MASLD. Fibrosis was identified in 90% of liver biopsies. The area under the receiver operating characteristic curves (AUROC) of MRE and TE for detection of high-grade fibrosis were 0.817 and 0.750, respectively, and not significantly different (p = 0.4785). CONCLUSION: We demonstrate that MRE and TE did not accurately predict high-grade fibrosis on liver biopsy. Between the two noninvasive imaging modalities, the correlation of identifying high-grade fibrosis was not statistically different; however, the AUROC for MRE was slightly superior to that of TE. Studies with larger cohorts will be required to validate these findings.

Transient elastography and diffusion-weighted magnetic resonance imaging for assessment of liver fibrosis in children with chronic hepatitis C.

BACKGROUND: Chronic hepatitis C (CHC) is a health burden with consequent morbidity and mortality. Liver biopsy is the gold standard for evaluating fibrosis and assessing disease severity and prognostic purposes post-treatment. Noninvasive alternatives for liver biopsy such as transient elastography (TE) and diffusion-weighted magnetic resonance imaging (DW-MRI) are critical needs. AIM: To evaluate TE and DW-MRI as noninvasive tools for predicting liver fibrosis in children with CHC. METHODS: This prospective cross-sectional study initially recruited 100 children with CHC virus infection. Sixty-four children completed the full set of investigations including liver stiffness measurement (LSM) using TE and measurement of apparent diffusion coefficient (ADC) of the liver and spleen using DW-MRI. Liver biopsies were evaluated for fibrosis using Ishak scoring system. LSM and liver and spleen ADC were compared in different fibrosis stages and correlation analysis was performed with histopathological findings and other laboratory parameters. RESULTS: Most patients had moderate fibrosis (73.5%) while 26.5% had mild fibrosis. None had severe fibrosis or cirrhosis. The majority (68.8%) had mild activity, while only 7.8% had moderate activity. Ishak scores had a significant direct correlation with LSM (P = 0.008) and were negatively correlated with both liver and spleen ADC but with no statistical significance (P = 0.086 and P = 0.145, respectively). Similarly, histopathological activity correlated significantly with LSM (P = 0.002) but not with liver or spleen ADC (P = 0.84 and 0.98 respectively). LSM and liver ADC were able to significantly discriminate F3 from lower fibrosis stages (area under the curve = 0.700 and 0.747, respectively) with a better performance of liver ADC. CONCLUSION: TE and liver ADC were helpful in predicting significant fibrosis in children with chronic hepatitis C virus infection with a better performance of liver ADC.

The association of ultra-processed food intake with adolescent metabolic dysfunction-associated steatotic liver disease in the NHANES.

INTRODUCTION: Metabolic dysfunction-associated steatotic liver disease (MASLD) has become a major public health concern. A thorough analysis of the link between ultra-processed food (UPF) intake and MASLD in the adolescent population is lacking. METHODS: Adolescent participants of the National Health and Nutrition Examination Survey (NHANES) pre-pandemic cohort were included. Different controlled attenuation parameter (CAP) cut-offs were used to assess MASLD. The percentage energy intake of UPF, categorized according to the NOVA classification, to total energy intake was taken as the main outcome marker. Structural equation modelling (SEM) was used to better quantify the causal connection between UPF and liver steatosis. RESULTS: UPF consumption constituted a median 75% (62-86) of total energy intake. There was no significant correlation between UPF intake and CAP (ρ = 0.061, p = 0.091). The median proportion UPF intake was not associated with steatosis severity. SEM similarly yielded a weak and non-significant correlation of 0.078. In participants with MASLD, total energy intake was significantly higher (p < 0.001) and sugar-containing beverage (SCB) consumption showed a non-significant trend towards higher consumption. CONCLUSIONS: No clinically relevant association between UPF intake and MASLD in adolescents could be demonstrated. Our results nonetheless suggest that total energy intake and consumption of SCBs are important contributors to paediatric obesity and MASLD.

Derivation of Splenic Stiffness in Subjects with Normal Liver Stiffness and No Vascular Liver Disease Using Transient Elastography with a Spleen-Dedicated Module: A Large Cross Sectional Study.

BACKGROUND: Liver and splenic stiffness measurements (LSM and SSM) are useful to predict varices and clinical decompensation in cirrhosis. SSM values are highly variable and overlapping and no guidelines exists on what constitutes normal SSM, that might limit interpretation of results. METHODS: Consecutive subjects with LSM < 6 kPa and reliable SSM (FibroScan630 Expert device with spleen-dedicated module) and no vascular liver disease were analysed for significant correlations of SSM values with age, sex, BMI, portal and splenic vein diameter, splenic diameter, liver fat and diabetes. Based on timeline of SSM, subjects were randomly assigned in 70:30 ratio into derivation [n = 502] and validation subset [n = 214]. RESULTS: Of 7200 subjects with simultaneous reliable LSM and SSM, 715 fulfilled the selection criteria (mean age: 43.8 ± 12.8 years, 67.2% male, mean BMI-26.4 ± 4.5 kg/m2). The mean SSM was 22.6 ± 5.8 kPa (c10-c90 percentile range: 15.2-31.3 kPa) and followed the normal distribution curve. In the derivation subset, mean SSM for males was higher than female (23.06 ± 6.2 vs. 21.78 ± 5.93 kPa; p = 0.028). SSM value correlated with LSM (r = 0.454, p = 0.001). Mean SSM in subjects with LSM 3-4, 4.1-5 and 5.1-6 kPa were 21.7 ± 5.8, 22.27 ± 5.67 and 23.76 ± 5.88 kPa (p value = 0.001). There was no difference in SSM based on age, BMI, diabetes and liver fat on ultrasound. Above results hold true for subjects in validation subset. CONCLUSION: SSM range in subjects with normal LSM and no vascular liver disease using spleen-dedicated module varies from 15.2 to 31.3 kPa, values being higher in male and not affected by Age, BMI, spleen size, liver fat and diabetes. Our results may serve as reference point in evaluation of SSM in compensated advanced liver disease patients.

Comparison of the diagnostic accuracy of shear wave elastography with transient elastography in adult nonalcoholic fatty liver disease: a systematic review and network meta-analysis of diagnostic test accuracy.

PURPOSE: To compare the diagnostic test accuracy (DTA) of shear wave elastography (SWE) to that of transient elastography (TE) for liver fibrosis grade assessment in nonalcoholic fatty liver disease adults. METHODS: MEDLINE, The Cochrane Library, and Web of Science were searched. Inclusion criteria were primary studies examining DTA of TE, point SWE (pSWE), two-dimensional SWE (2D-SWE), or magnetic resonance elastography (MRE) with liver biopsy. Network meta-analysis was conducted using a Bayesian bivariate mixed-effects model. RESULTS: For fibrosis grade 2 or higher, 15 studies with 25 observations (16 observations for TE, 1 for MRE, 4 for pSWE and 2D-SWE; 2,066 patients) were included; the pooled sensitivity and specificity were 0.79 (95% credible interval (CrI) 0.70-0.86; 95% prediction interval (PI) 0.36-0.96) and 0.73 (95% CrI 0.62-0.82; 95% PI 0.23-0.96) for TE, 0.68 (95% CrI 0.48-0.83; 95% PI 0.23-0.94) and 0.75 (95% CrI 0.53-0.88; 95% PI 0.24-0.97) for pSWE, 0.85 (95% CrI 0.70-0.93; 95% PI 0.40-0.98) and 0.72 (95% CrI 0.49-0.86; 95% PI 0.20-0.96) for 2D-SWE, respectively. The proportion of studies classified as unclear in QUADAS-2 was high, and the results were heterogeneous. CONCLUSION: 2D-SWE could be recommended as TE is for liver fibrosis assessment. The protocol of this systematic review and network meta-analysis has been registered in PROSPERO (CRD42022327249). All included primary papers have already been published and the information and data can be used freely.

Screening for advanced liver disease incorporating the use of transitional elastography in primary care. / Detección de enfermedad hepática avanzada incorporando el uso de la elastografía de transición en atención primaria.

OBJECTIVES: To describe the proportion of patients with liver fibrosis in at-risk populations in primary care (PC). To know the agreement between FIB-4 and transitional elastography (TE), interobserver agreement between PC and hospital care (HC) in TE, and associated risk Factors (RF). METHODS: Observational, descriptive, cross-sectional study in ≥16 years of age with RF for chronic liver disease. Sex and age, RF (alteration of liver tests [LT], metabolic syndrome, diabetes, obesity, alcohol consumption, hepatic steatosis), and FIB-4, controlled attenuation parameter and TE in PC and in HC, were collected. According to a consensus algorithm, vibration-controlled TE was performed in PC in patients with FIB-4≥1,3, and those with measurement ≥8kPa were referred to HC. RESULTS: 326 patients were studied. 71% were not referred to HC, due to liver stiffness <8kPa. 83 of the 95 derivations did TE in HC. 45 (54%) had TE ≥8, and 25 (30%) ≥12. The proportion of patients with stiffness ≥8kPa was 13,8% (45/326) and ≥12kPa, 7,6% (25/326). The predictive values of the FIB-4 were low. The interobserver correlation coefficient between TE in PC and HC was 0,433. Variables associated with TE ≥8 in PC: LT alteration, diabetes and steatosis. With TE ≥12: LT alteration, diabetes and obesity. PREDICTOR VARIABLES: LT alteration and obesity. CONCLUSIONS: The study supports the sequential performance of serum indices and TE as a screening for fibrosis in the at-risk population in PC, which allows a reduction in the percentage of patients referred to AH, and a better stratification of risk patients.

Diagnostic performance of new BAST score versus FIB-4 index in predicating of the liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND AND AIM: Metabolic dysfunction-associated steatotic liver disease (MASLD) formerly known as non-alcoholic fatty liver disease (NAFLD) is the most common liver condition globally. The FIB-4 test is used to detect fibrosis in fatty liver disease but has limited accuracy in predicting liver stiffness, resulting in high rates of false positives and negatives. The new BAST scoring system, incorporating waist circumference, AST, and BMI, has been developed to assess the presence of fibrosis in NAFLD patients. This study compares the effectiveness of BAST and FIB-4 in predicting liver fibrosis in MASLD patients. PATIENTS AND METHODS: The study included 140 non-diabetic MASLD patients who underwent transient elastography measurement. BAST score and FIB-4 were calculated for each patient. Patients were grouped based on fibrosis severity; F1, F2, and F3-F4. The sensitivity and specificity of the BAST score and FIB-4 were assessed using receiver operating characteristic curves. RESULTS: The BAST score increased significantly with fibrosis progression from F1 to F3-F4. In differentiating advanced fibrosis (F2-F3) from mild/moderate fibrosis (F1-F2), the BAST score at cutoff ≤ - 0.451 showed better diagnostic performance with 90.70% sensitivity, 74.07% specificity, 84.8% PPV and 83.3% NPV compared to FIB-4 that had 60.47% sensitivity, 50.0% specificity, 65.8% PPV and 44.3% NPV. Similarly, for differentiating between F1 and F2 fibrosis, the BAST score at cutoff ≤ - 1.11 outperformed FIB-4, with 80.23% sensitivity, 79.49% specificity, 89.6% PPV and 64.6% NPV, while FIB-4 had 59.30% sensitivity, 51.28% specificity, 72.9% PPV and 36% NPV. CONCLUSIONS: The BAST score is a better predictor of liver fibrosis in MASLD compared to FIB-4, especially in cases of advanced fibrosis or cirrhosis.

Dynamic Changes in ELF Score Predict Hepatocellular Carcinoma in Chronic Hepatitis B Patients Receiving Antiviral Treatment.

Enhanced liver fibrosis (ELF) score is a noninvasive assessment for liver fibrosis. We aimed to evaluate the performance of changes in ELF score 3 years apart in combination with liver stiffness measurement (LSM)-hepatocellular carcinoma (HCC) score to predict HCC in chronic hepatitis B (CHB) patients. This is a prospective cohort study. Patients who underwent transient elastography (TE) examinations and at intermediate or high risk of HCC defined by LSM-HCC score were invited to repeat the examination about 3 years later. Their serum samples at these two time points were retrieved to assess the ELF score changes. The primary endpoint was HCC. There were 445 CHB patients (males: 73.9%; mean age: 51.6 ± 10.3 years) who received two TE examinations and ELF scores. Among them, 252 (56.6%) and 193 (43.4%) patients were at intermediate and high HCC risk at first assessment defined by LSM-HCC score, respectively. Kaplan-Meier analysis showed that the changes in ELF score could stratify the HCC risk in both intermediate- and high-risk patients defined by LSM-HCC score (p < 0.001 for intermediate-risk group; p = 0.011 for high-risk group). Patients remained having mild or moderate fibrosis at both assessments had the lowest risk of HCC (4.0%), followed by patients with fibrosis regressed (11.3%; p = 0.014) during a mean follow-up of 163 months. Patients remained having or progressed to severe fibrosis were at highest risk of HCC (>20%). Consistent findings were demonstrated in patients at both intermediate and high risk of HCC defined by LSM-HCC score. Dynamic changes in ELF score provided additional value to LSM-HCC score for stratifying HCC risk in CHB patients.

Imeglimin for Type 2 Diabetes Mellitus: Its Efficacy and Insight Into the Potential Benefit for Renal and Liver Function.

Introduction Imeglimin is a novel oral antihyperglycaemic drug used to treat type 2 diabetes mellitus (T2DM). In 2022, its clinical use was approved in Japan; however, there is limited data on its practical efficacy. Thus, we retrospectively investigated the clinical efficacy of imeglimin for six months at the National Defense Medical College, Tokorozawa, Japan. Material and methods We conducted a single-center retrospective analysis to elucidate the efficacy of imeglimin in the treatment of T2DM. Ten patients were enrolled, and their biomarkers and geographic data were analyzed. The primary endpoint was the change in HbA1c level at six months after imeglimin treatment compared to the baseline values. Other demographic and laboratory parameters, including sex, age, BMI, renal function, liver function, lipid profile, and transient elastography data, were also analyzed. Results A significant improvement in the HbA1c levels (8.1 % at baseline to 6.9 % at six months after treatment, P value = 0.01) was observed in this study, suggesting that imeglimin is a promising option for treating T2DM. In addition, no negative effects on renal function were observed, and albumin levels tended to decrease from baseline values. Among the nonalcoholic fatty liver disease (NAFLD) cases, liver conditions, especially fat content, tended to improve in this short-term period. Conclusions Imeglimin is suggested to have a beneficial effect not only on glycemic control but also on renal and liver function. However, further studies are required to better understand the long-term efficacy of this drug.

Effect of Indo-Mediterranean diet versus calorie-restricted diet in children with non-alcoholic fatty liver disease: A pilot randomized control trial.

BACKGROUND: Dietary interventions and increased physical activity are the cornerstones for management of the paediatric non-alcoholic fatty liver disease (NAFLD). Though, no specific diet has been proven superior, Indo-Mediterranean diet (IMD) has shown promise in adult literature. Thus, we aimed to compare the effect of IMD and a standard calorie-restricted diet (CRD) in Indian overweight children and adolescents with biopsy-proven NAFLD. METHODS: Thirty-nine consecutive biopsy-proven NAFLD children between the ages of 8 and 18 years were randomized into either IMD or CRD for 180 days, and various parameters were evaluated at baseline and then after 180 days (NCT05073588). RESULTS: A total of 34 subjects (18 in IMD and 16 in CRD group) completed the study. There was a significantly higher decrease in controlled attenuation parameter (CAP) values (as a marker of hepatic steatosis; on transient elastography) (95% CI: 4.2-73.4, p = 0.042), weight (95% CI: 0.75-5.5, p = 0.046) and body mass index (BMI) (95% CI: 0.21-2.05, p = 0.014) (but not in Pediatric NAFLD Fibrosis Index or PNFI; as a marker of hepatic fibrosis) in IMD group compared to the CRD group. Liver stiffness measurement, serum cholesterol and low-density lipoprotein levels and HOMA-IR decreased only in the IMD group (p < 0.001). Our statistical model showed that delta-Weight was the only independent variable associated with delta-CAP. CONCLUSION: Both IMD and CRD can improve the various anthropometric, clinical, imaging and biochemical parameters but IMD was superior to CRD in terms of reducing CAP values and weight/BMI over 180 days in overweight/obese NAFLD children.

Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-analysis.

BACKGROUNDS/AIMS: Despite advances in antiviral therapy for hepatitis C virus (HCV) infection, hepatocellular carcinoma (HCC) still develops even after sustained viral response (SVR) in patients with advanced liver fibrosis or cirrhosis. This meta-analysis investigated the predictive performance of vibration-controlled transient elastography (VCTE) and fibrosis 4-index (FIB-4) for the development of HCC after SVR. METHODS: We searched PubMed, MEDLINE, EMBASE, and the Cochrane Library for studies examining the predictive performance of these tests in adult patients with HCV. Two authors independently screened the studies' methodological quality and extracted data. Pooled estimates of sensitivity, specificity, and area under the curve (AUC) were calculated for HCC development using random-effects bivariate logit normal and linear-mixed effect models. RESULTS: We included 27 studies (169,911 patients). Meta-analysis of HCC after SVR was possible in nine VCTE and 15 FIB-4 studies. Regarding the prediction of HCC development after SVR, the pooled AUCs of pre-treatment VCTE >9.2-13 kPa and FIB-4 >3.25 were 0.79 and 0.73, respectively. VCTE >8.4-11 kPa and FIB-4 >3.25 measured after SVR maintained good predictive performance, albeit slightly reduced (pooled AUCs: 0.77 and 0.70, respectively). The identified optimal cut-off value for HCC development after SVR was 12.6 kPa for pre-treatment VCTE. That of VCTE measured after the SVR was 11.2 kPa. CONCLUSION: VCTE and FIB-4 showed acceptable predictive performance for HCC development in patients with HCV who achieved SVR, underscoring their utility in clinical practice for guiding surveillance strategies. Future studies are needed to validate these findings prospectively and validate their clinical impact.