Introduction To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM). Methods In this prospective randomized, double-blind, placebo-controlled trial, we assigned 106 patients with NAFLD and T2DM to receive empagliflozin 10 mg ( n = 35), pioglitazone 30 mg ( n = 34), or placebo ( n = 37) for 24 weeks. Liver fat content and liver stiffness were measured using fibroscans. Body composition assessment was performed by dual-energy x-ray absorptiometry (DEXA) scans. The primary end point was change from baseline in liver steatosis, using the controlled attenuation parameter (CAP) score. Results A borderline significant decrease in CAP score was observed with empagliflozin compared to placebo, mean difference: − 29.6 dB/m (− 39.5 to − 19.6) versus − 16.4 dB/m (− 25.0 to − 7.8), respectively; p = 0.05. Using multivariate analysis, we observed a significant reduction in the placebo-corrected change in liver stiffness measurement (LSM) with empagliflozin compared to pioglitazone: − 0.77 kPa (− 1.45, − 0.09), p = 0.02, versus 0.01 kPa (95% CI − 0.70, 0.71, p = 0.98), p for comparison = 0.03. Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group ( p < 0.001 and p = 0.01, respectively) and both were increased in the placebo and pioglitazone groups. There were no serious adverse events in either group. Conclusion Treatment for 24 weeks with empagliflozin, in contrast to pioglitazone, was associated with improvement of liver steatosis and fibrosis in patients with NAFLD and T2DM. In addition, body weight and abdominal fat area were decreased in the empagliflozin group. Trial Registration Iranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01011-3.
Although FLI had acceptable discriminatory power in the diagnosis of NAFLD, WC was a simpler and more accessible index with a similar performance.
BackgroundA strong association between obesity and non-alcoholic fatty liver disease (NAFLD) has been reported.ObjectivesThis study was conducted to evaluate if new obesity indices, including a body shape index (ABSI) and body roundness index (BRI), have stronger associations with NAFLD than waist-to-hip ratio (WHR) and waist-to-height ratio (WHtR).MethodsIn this cross-sectional study, we utilized the data of 4,872 participants aged 18 - 74 years from a cohort study conducted among 6,143 subjects in northern Iran. Logistic regression analysis was performed on NAFLD as the outcome and obesity measures (based on Z-score values) as potential predictors. Receiver operating characteristic (ROC) analyses were conducted, in which NAFLD was considered as a reference variable and obesity measures as classification variables. The discriminatory ability of the obesity measures was reported based on area-under-the-curves, and the related cut-off points of BRI and WHtR were determined using the Youden index (YI).ResultsBased on our results, BRI (OR = 5.484 for men and OR = 3.482 for women) and WHtR (OR = 5.309 for men and OR = 3.854 for women) showed a higher association with NAFLD than ABSI (OR = 1.363 for men and OR = 1.003 for women) and WHR (OR = 3.123 for men and OR = 1.628 for women). The optimal cut-off points for BRI were 4.00 (sensitivity = 82.7%, specificity = 70.8%) for men and 5.00 (sensitivity = 83.3%, specificity = 71.7%) for women. The optimal cut-off points for WHtR were 0.533 (sensitivity = 82.7%, specificity = 70.8%) for men and 0.580 (sensitivity = 83.3%, specificity = 71.7%) for women.ConclusionsWhile BRI and WHtR have equally strong associations with NAFLD, ABSI and WHR have weaker associations with NAFLD than BRI and WHtR.
Cases of colorectal cancer (CRC) have increased dramatically in Middle Eastern and other Asian countries. Many studies indicate an important role of environmental factors, including trace elements as an etiology of cancer. This study aims to assess the concentration of eight trace elements in cancerous and adjacent non-cancerous tissues in case of CRC. In a cross-sectional study, conducted between March 2015 and February 2016, zinc (Zn), chromium (Cr), manganese (Mn), tin (Sn), copper (Cu), aluminum (Al), lead (Pb), and iron (Fe) levels were evaluated among patients suffering from CRC. All the patients underwent a full colonoscopy. Multiple samples were taken from cancerous lesions and adjacent healthy tissues that kept a minimum distance of 10 cm from the lesions. These specimens were kept at -80 °C. The classic flame atomic absorption spectroscopy (FAAS) method was applied in this study. The mean age of the study population was 55.6 ± 12.8. The median of Zn, Cr, Cu, Al, and Pb in cancerous tissues was significantly higher than that of healthy tissues (P < 0.05). Nevertheless, the median of Mn, Sn, and Fe was significantly lower than that of non-cancerous tissues (P < 0.05). Between colon and rectal specimens, we did not find a difference between Cr and Al levels and Zn, Sn, and Cu levels in cancerous and healthy tissues, respectively. We revealed that gender and history of smoking may influence the level of some trace elements. We revealed that the levels of eight elements were significantly different for cancerous and healthy tissues. This may play a role in developing CRC. These findings reflect the importance of environmental pollution in this setting.
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