Active clinical trials for "Fatty Liver"

Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid accumulation in subjects that consume less than 20g ethanol per day, without other known causes as drugs consumption or toxins exposure. In Western countries, the rate of this disease lies about 30% in the general adult population. The process of developing NAFLD can start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy is considered the "gold standard" of steatosis, fibrosis and cirrhosis. However, it is rarely performed because it is an invasive procedure and investigators are focusing in the application of non-invasive liver damage scores for diagnosis. The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as unbalanced diets and overnutrition as well as by lack of physical activity in the context of a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle modifications. Weight loss, exercise and healthy eating habits are the main tools to fight NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are necessary. With this background, the general aim of this project is to increase the knowledge on the influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in future obese people.

To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation. The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance. The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.

Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.

The worldwide impact of obesity suggests an urgent need for solutions to decrease its burden on modern society. It has been generally understood that obesity is caused by a simple imbalance in the intake of energy in the form of food compared with the expenditure of energy by the body the human microbiota consists of a wide variety of microorganisms, including bacteria, archaea, fungi, viruses, protozoans and yeast. These organisms colonize both the exterior and interior of the human body in numbers that are equivalent to those of human cells of their host. Current research has identified numerous physiological and psycho-modulatory functions of the gut microbiota, including digesting food, stimulating cell growth, strengthening the immune system, preventing allergies and diseases, and impacting emotion. The gut microbiota can contribute to host physiology through metabolite production, such as short-chain fatty acids (SCFAs), which can modulate the intestinal barrier and inflammation 9.Dysbiosis of the gut microbiota, defined as a decrease in commensal bacteria levels and diversity, has been linked to diseases such as stomach/colon/liver cancer 2, obesity 9,inflammatory bowel disease (IBD) and anxiety.

This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects

Nonalcoholic fatty liver disease (NAFLD) is the most common and harmful chronic liver disease. NAFLD accounts for 49.3% of the total number of chronic liver disease patients in China. It is important to effectively prevent and control NAFLD and its related diseases. Previous studies show the level of serum uric acid is significantly elevated in patients with NAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism. It is a new therapeutic target for NAFLD. This study is aimed to further confirm that hyperuricemia is a new risk factor for NAFLD through a large sample prospective study. Furthermore, this study explore whether Xanthine oxidase (XO), a key enzyme in uric acid metabolism, plays an important role in regulating NAFLD.

A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled. Empagliflozin will be incorporated into two of the treatment arms in an open-label manner.

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.

Non-alcoholic fatty liver disease (NAFLD) is associated with obesity and type 2 diabetes mellitus (T2DM) and is characterised by excess liver fat on imaging or histology. NAFLD affects up to 25% of the Western population. It's more aggressive form is non-alcoholic steatohepatitis (NASH) characterised by cell injury, inflammation and fibrosis, and is associated with increased mortality from liver and cardiovascular disease. Currently, there is no specific treatment for NASH. Diet and exercise-induced weight loss remain the only recommended options. However, maintaining weight loss in the long term is difficult. There is therefore a significant unmet need for effective therapy in patients with NASH that can address the underlying mechanisms of disease. Although preliminary observational evidence suggests that bariatric/metabolic surgery, especially RYGB can improve NASH, no controlled trials to date has confirmed the efficacy of surgery compared to standard weight loss programs. Also, while animal and clinical studies have shown that bariatric surgery exerts weight-independent effects on glucose metabolism, it is yet unknown if the observed effects of bariatric/metabolic surgery on NASH are due to weight loss alone or result from additional, weight-independent mechanisms, like in the case of T2DM. If the effect of surgery on inflammation, liver fibrosis and other mechanisms of cardiometabolic risk were found to be independent on weight reduction, there would be profound and far-reaching implications for both the treatment and the understanding of NASH, cardiovascular disease and obesity-related cancers. This project will investigate the hypothesis that, similarly to surgical control of diabetes, bariatric/metabolic surgery can also exert weight-independent effects on mechanisms of disease in NAFLD/NASH (i.e. influence on lowgrade inflammation and markers of fibrosis)