View clinical trials related to Fatty Liver.
Filter by:Non-alcoholic fatty liver disease (NAFLD) is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), cardiovascular diseases (CVD) and increased risk of cancer development. NAFLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from non-alcoholic fatty liver (NAFL) to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% non-alcoholic steatohepatitis (NASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, there is a striking lack of awareness on all levels of NAFLD. Furthermore, little to know data are available concerning the quality of life of NAFLD patients. Additionally, the majority of NAFLD patients are currently not detected due to the lack of non-invasive methods to diagnose NAFLD. Most of these patients, as a first contact in the healthcare system, will be found in the outpatient clinic of the general practitioner (GP). To date, it is not clear what the burden is of NAFLD and related diseases in at risk subjects in primary care. Therefore, identification of NAFLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health.
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.
Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment.Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle. Thus, this study aims at â‘ evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); â‘¡investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.
Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the obesity epidemic, NAFLD is becoming the main etiology of liver transplantation in the US. Currently, there are no FDA approved pharmacological treatments for NAFLD. Weight loss through lifestyle modifications, pharmacotherapy and bariatric surgery can be effective strategies for the management of NAFLD. Even though substantial weight loss and improvement in NAFLD can be achieved with bariatric surgery, only a small proportion of patients with obesity undergo surgery. Very-low calorie diets (VLCD) are replacement meals manufactured to substitute natural foods and limited total intake of 800-960 kcal in divided meals. Very low-calorie diets can produce substantial weight loss of 10% over 2 to 3 months. We hypothesize that VLCD reduce liver steatosis and, fibrosis measured non-invasively with transient elastography. Our main aim is #1 to assess the effect of VLCD on liver fatty infiltration and fibrosis. We also have three exploratory aims exploring novel pathogenic factors that mediate the improvement of NAFLD by VLCD: #2 assess the effect of VLCD on micro RNAs (miRs) associated with pathophysiology of NAFLD: #3 assess the effect of VLCD on changes of salivary and fecal microbiome in the setting of NAFLD: #4 to determine the effect of VLCD on platelet function. This pilot project will produce preliminary data for the development of a larger grant application to study the efficacy of VLCD in the management of NAFLD. Furthermore, it will potentially identify factors that mediate improvement of NAFLD after VLCD. We will treat 10 subjects with obesity and NAFLD for 8 weeks with VLCD or lower calorie diet (control group) and obtain transient elastography before and after the interventions along with other measurements of interest. Our project may have significant impact by establishing VLCD as a clinically effective option for the improvement of liver steatosis and fibrosis in patients with obesity and NAFLD ineligible or without access to bariatric surgery.
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
The overarching aim of this project is to investigate effects of dietary interventions on nonalcoholic fatty liver disease (NAFLD) severity and to delineate the relationship with improvements in metabolic aberrations in liver-, fat- and muscle tissue, using a panel of state-of-the art techniques. The investigators will conduct a randomized clinical trial with three arms to investigate if micellar cassein isolate and whey protein supplementation as part of a high-protein diet during 4 weeks of weight maintenance and 20 weeks of hypocaloric intake (30% energy restriction) inducing modest weight loss (5% of baseline weight) has beneficial effects on NAFLD severity and metabolic aberrations compared to normal diet in NAFLD patients. It is hypothesized that: (i) a high-protein diet improves liver disease severity and metabolic function compared to a normal protein diet; (ii) Cassein provides greater benefits than whey; and(iii) these effects manifest during both weight maintenance and weight loss.
Non-Alcoholic Fatty liver Disease (NAFLD) is a Public Health problem. NAFLD affects nearly 25% of the world's population. NAFLD includes hepatic complications related to insulin resistance and metabolic inflammation. NAFLD is in fact a continuum of liver abnormalities that progresses from pure steatosis, to Non-Alcoholic Steato-Hepatitis-NASH, then to hepatic fibrosis, cirrhosis and even the appearance of primary liver cancer (hepatocellular carcinoma). Although many drugs are being tested for advanced forms of NAFLD, steatohepatitis (NASH) with fibrosis and post-NAFLD cirrhosis, there are currently no drugs with marketing authorization. Excessive and unbalanced dietary intake, excessive physical inactivity and lack of regular physical activity are major contributors to the development of NAFLD. It is therefore logical that the preventive and curative treatment of NAFLD is based on hygienic and dietary measures. Physical exercise alone in patients with NAFLD has been shown to improve liver steatosis even in the absence of weight loss. Proof of concept of the improvement in hepatic steatosis has been shown to be achieved by physical activity, whether or not associated with dietary management. More recently, APA (Adapted Physical Activity) is thus seen as a new modality of care that will become central to the prevention and treatment of NAFLD. The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasive inflammation and hepatic fibrosis in patients with NAFLD subjected to the application of personalized dietary measures without or with the performance of personalized and reproducible physical activity via the prescription of adapted physical activity. The evaluation will be carried out initially, at the end of the operation and 6 months after the end of the operation in order to look for a persistent effect of the modification in lifestyle.
Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.