Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD...
Liver Transplant; ComplicationsNAFLDThis is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
Efficacy and Safety of a Probiotic Composition as Adjunct in MAFL Management
Non Alcoholic Fatty LiverSome studies have shown beneficial results with probiotics on hepatic function of subjects with fatty liver, but significant variability has been noted among probiotic formulations. This study aims at providing a comprehensive characterization of the effect of a particular probiotic formula in hepatic function of said subjects.
Cigarette Smoking in Non-alcoholic Steatohepatitis
Non-Alcoholic Fatty Liver DiseaseThis non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.
Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Spin-lock...
Non-alcoholic Fatty Liver Disease (NAFLD)Non-alcoholic Steatohepatitis (NASH)Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.
Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects
Overweight and ObesityCardiovascular Diseases2 moreObesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO). In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.
Multicenter Registry of Nonalcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver DiseaseNon-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide affecting as much as 25% of the world's population. The spectrum of NAFLD ranges from non-alcoholic fatty liver to non-alcoholic steatohepatitis (NASH), the latter being associated with a progressive course towards fibrosis and a higher risk of developing cirrhosis and hepatocellular carcinoma. Patients with type 2 diabetes are particularly at higher risk of developing fibrosis and advanced liver disease. Since NASH and its consequences will only occur in a minority of patients, it is of paramount importance to identify this population to offer them proper care. It is well known that there is a lack of awareness about the potential consequences of NAFLD, not only in the general population but also in the medical community. Patients with NAFLD are frequently lost during follow up and, additionally, approach to these patients is sub-optimal and heterogeneous among physicians. An attractive approach to applying best medical practices to patients with NAFLD is to generate a multicentre registry. Clinical registries comprise a set of systematic collected and stored data focused on a specific condition. The information stored in a registry provides relevant information about a disease and, through a process of error detection, ensures data quality and reliability. A NAFLD registry is an essential tool for providing relevant information such as epidemiological aspects of the disease, outcomes, and treatment effectiveness. As far as we concern, this would be the first registry of NAFLD in our region, a region where the disease behaves in a more aggressive way in comparison with other regions and hemispheres. By generating this registry, we are confident that we will obtain objective information on the characteristic of patients with NAFLD in our region, not only of the disease characteristics but also of social determinants that might influence disease outcomes. By being a prospective study, it allows an adequate patient follow up.
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver...
Non-Alcoholic Fatty Liver DiseaseThe purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
Non-Alcoholic Fatty Liver DiseaseObesityOne of the comorbidities of obesity is nonalcoholic fatty liver disease (NAFLD). L-citrulline is a non-protein amino acid that has shown positive effects on the degree of fat retention and metabolic profile in NAFLD. The objective is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo and an experimental group that will receive 6 g of l-citrulline per day for eight weeks.
Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease
Non-Alcoholic Fatty Liver DiseaseObesityPrimary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Adults with obesity and non-alcoholic NAFLD were allocated based on preference and motivation to undergo the POSE 2.0 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE2.0 procedures on NAFLD parameters and metabolic profile. Co-primary endpoints included improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary endpoints included total body weight loss (TBWL), change in serum measures of hepatic steatosis and insulin resistance, and device safety.
Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver DiseaseThe aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.