Active clinical trials for "Fatty Liver"

The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. The presence of a NAFLD is positively correlated with the severity of insulin resistance and dysglycemia in this population. The presence of NAFLD worsens the prognosis of T2D with an increased cardiovascular risk. This hepatic impairment would also increase the risk of microvascular complications, especially nephropathy. Conversely, T2D increases the risk of transition from NAFLD to NASH and then to hepatic fibrosis and its related complications (cirrhosis, hepatocellular carcinoma). The risk of progression of liver steatosis to fibrosis is also more important as diabetes and insulin resistance are more severe. In addition to diabetes and insulin resistance, other risk factors are associated with more severe liver damage such as changes in microbiota. Indeed, it has already been described a smaller amount of bacteroides in the microbiota of subjects with T2D and the most severe hepatic impairment. The treatment of NAFLD/NASH is poorly codified without approved drugs in this indication, while many phase 3 trials with candidate drugs are undergoing. Life-style measures (physical activity and low carbohydrate/calorie diet) can limit the progression from NAFLD to more severe liver fibrosis. Some bariatric surgery studies have also shown good results in this situation. Pharmacological interventions are also reported with proven efficacy of pioglitazone, vitamin E and orlistat. The OPT2MISE study has recently shown the superiority of insulin pump (or continuous sub-cutaneous insulin infusion: CSII) compared to multiple daily insulin injections (MDI) to improve glycemic control in a population of patients with T2D in failure of well-titrated MDI. In addition, treatment with CSII showed a 45% decrease in insulin resistance (assessed by HOMA-IR) in a population of newly diagnosed T2D. In light of these data, investigators hypothesize that the introduction of insulin pump treatment in a population of subjects with T2D and NAFLD, by improving insulin sensitivity, could reduce fatty liver content compared to standard MDI treatment.

A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with NAFLD. Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first 2-weeks (N= 16).

A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).

In the presented project, the role of heme oxygenase 1 and 2 in the procesess associated with fibroproduction in the chronic HCV infection will be studied. Heme oxygenase expression will be evaluated by the techniques of molecular genetics and immunohistochemistry, both in the liver tissue and in peripheral blood mononuclear cells. These parameters will be correlated with basic virological and clinical characteristics of the chronic HCV infection. The investigators' expected results may help in understanding the mechanisms of fibroproduction in chronic HVC infection and, therefore, contribute to explain individual differences in the development of chronic HCV infection.

Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most common menopausal disorders and chronic diseases to which women are more exposed during this life stage. Therefore, menopausal women may represent a target for evaluating the effectiveness of nutritional intervention studies based on protective diets against the common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis. Lipidomics aims to study the lipid molecules in a "dynamic" way and allows to define not only structure and functions of a set of lipid species present in an organism, but also the changes that occur during cell metabolism under physiological and pathological conditions in order to understand their role as part of the complex functional balance of a living organism. Quantitative and qualitative determination of fatty acids profiles in cell membranes allows to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes, such as inflammation, stress, nutrition. Scientific evidence has shown that, for nutritional studies, the most representative cell is the erythrocyte, which is a biomarker of an individual's general state of health. In fact, the evaluation of the fatty acid composition contained in the membrane of red blood cell, which has an half-life of four months, allows to follow the nutritional status of a subject and to acquire information about his eating habits, with special reference to fat consumption. The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state which is often altered in patients with metabolic diseases, hepatic steatosis and obesity. Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years, will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical examination with blood pressure and anthropometric measurements (weight, height, waist and hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled will undergo medical examination and dietary control to assess the adherence to the dietary pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry after 4 and 16 weeks as well as blood samples after 16 weeks. The results will be analyzed using appropriate statistical tests. All patients will be made to sign an informed consent.

Chronic liver diseases of differing etiologies are among the leading causes of morbidity and mortality worldwide [1]. Chronic liver disease progresses through different pathological stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic fibrosis and cirrhosis [2]. Assessment of the stage of liver disease is important for diagnosis, treatment, and follow-up both during treatment and after cessation of treatment. A liver biopsy is the oldest and most accurate method used to evaluate liver histology and the progression of chronic liver disease. Furthermore, different histological scoring systems have been developed and modified [3]. A liver biopsy is considered the gold standard for assessing liver histology [4]. During the pathological progression of liver fibrosis, excessive amounts of extracellular matrix build up; furthermore, serum levels of various biomarkers change, in addition to the appearance of new biomarkers in the serum during the different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing liver fibrosis have been developed, and they are frequently used in clinical practice. They have been validated in different studies, and some were found to be highly accurate in the assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used as the standard reference method for evaluating the accuracy of noninvasive methods. There are limited studies documenting the cost effectiveness of non invasive markers over invasive technique. Most people with chronic Hepatitis B or C are unaware of their infection, putting them at serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About 20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a longitudinal prospective study to assess the cost effectiveness of these diagnostic measures. We planned to conduct a retrospective followed by prospective cohort study among all cases that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort study, we will collect data from hospital information system for all patients with HBV infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020 will serve as a cohort for prospective design. We will collect socio-demographic data, clinical data, family history, personal history, medical history, anthropometry, biochemical and radiological data from each patient. We will also be conducting a cost effective analysis for various non invasive markers against biopsy as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts. For prospective cohort study, after evaluation of baseline biopsy results, the cases with metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence of development and progression of fibrosis. No additional investigation or test will be asked to the patient for the study. We will also develop a predicting model for development and progression of fibrosis.

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

The purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (NAFLD).

The goal of this study is to investigate comparisons between the intestinal microbiome in patients with obesity and in patients with obesity and Non-Alcoholic Fatty Liver Disease (NAFLD). With this protocol we hope to better understand how the microbiome of each individual works with disease progression.

The purpose of this study is to document how often specific genotypes known to be associated with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and investigate whether these genotypes are associated with increased susceptibility to NASH.