View clinical trials related to Nonalcoholic Fatty Liver Disease.
Filter by:Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).
Nonalcoholic fatty liver disease (NAFLD) is a rapidly growing epidemic worldwide and is an increasingly important etiology of chronic liver disease and hepatocellular carcinoma. NAFLD affects approximately 90 million people in the United States (US) amounting to an annual cost of $100 billion yearly. It is projected to become the leading cause of liver transplantation in the US by 2030 and is associated with significant morbidity and mortality. NAFLD is a spectrum of liver diseases, ranging from simple steatosis (nonalcoholic fatty liver, NAFL) to hepatic steatosis associated with inflammation (nonalcoholic steatohepatitis, NASH), which can be associated with liver scarring (hepatic fibrosis) and cirrhosis. There are limited therapeutic options that have been shown to effectively reduce or reverse the progression of disease. Lifestyle modification is the backbone of therapy, but difficult to achieve. A modest amount of weight loss of approximately 3% can reduce liver steatosis and a 10% weight loss can reduce the NASH and improve liver fibrosis. The American Association of the Study of Liver Diseases (AASLD) guidelines state that "a combination of a hypocaloric diet (daily reduction by 500-1000 kcal) and moderate intensity exercise is the best likelihood of sustaining weight loss over time." There are several barriers to adopting a healthy lifestyle involving both patient and physician limitations. The aim of this study is to engage patients in a lifestyle intervention program that has already been shown to be successful in achieving weight loss goals and adopting healthier lifestyle patterns. The CDC Diabetes Prevention Program, (DPP) was a large (n=3,234) multicenter study aimed to evaluate the effect of lifestyle intervention or treatment with metformin on the incidence of type 2 diabetes (T2DM). Lifestyle intervention reduced the incidence of T2DM by 58% (95% CI, 48-66%) and metformin reduced the incidence by 31% (95% CI, 17-43%) as compared to placebo. To prevent one case of diabetes over three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. The CDC DPP program has been adapted and tested in the multiple different community and state-wide programs including the YMCA, WorkWellNYC and NYS DPP. In these real-world models, the life style intervention program has been delivered in a group-based format by DPP lifestyle coaches. These programs have been successful like that of the randomized trial and improvements were sustainable at 6 and 12 month follow up after completion of the program. The program is now available and reimbursable through Medicare (Medicare Diabetes Prevention Program). In this pilot study, the researchers will enroll 20 patients with NAFLD in an adapted DPP program and follow study participants for 1 year. The rationale for the proposed research is to apply the DPP to NAFLD because of the close relationship with Diabetes and determine the real-world outcome of the DPP program on weight loss in patients with NAFLD. If the researchers illustrate that weight loss can be achieved and is sustainable in patients with NAFLD enrolled in lifestyle intervention programs, the researchers can develop innovative approaches to deliver such a program nationwide in a cost-effective and sustainable manner.
The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
The 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.
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. The study has a prospective part planned for 2021 and a retrospective part which includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut microbiota composition, its metabolites, levels of inflammatory and other markers of the disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control patients) as well as in retrospective groups (chronic heart failure with preserved and reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate the association between gut microbiota composition and its metabolites, levels of inflammatory and other markers of the disease in retrospective and prospective groups.
This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
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.
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis