The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis...
Non-Alcoholic SteatohepatitisThe term non-alcoholic fatty liver disease (NAFLD) is used to describe a range of chronic liver diseases that range from steatosis to steatohepatitis, advanced fibrosis, cirrhosis, or excessive alcohol consumption or other causes of steatosis. In this spectrum, Non-Alcoholic Steatohepatitis (NASH), which defines liver damage accompanied by steatosis and inflammation (hepatitis), is one of the most common causes of chronic liver disease worldwide, especially in developed and developing countries, and is present in 15-35% of the general population. Individuals diagnosed with NASH primarily experience deterioration in liver functions, but patients are also affected in terms of vascular structures, immunopathological responses, functional and psychosocial conditions. It is seen that in addition to intrahepatic lipid content, inflammatory markers, liver enzymes, and liver functions, cardiopulmonary endurance, physical activity level, and muscle strength are also affected in these patients, so it is evaluated for the diagnosis and planning of the treatment of the disease. There is no drug with proven efficacy in the treatment of the disease. Since a significant proportion of NASH patients have obesity, Type II Diabetes Mellitus or dyslipidemia, the focus of treatment is to control risk factors or protect the liver from harmful factors such as TNFα. Therefore, the mainstay of treatment, for now, seems to be weight control with a lifestyle change, including regular exercise training and diet control. Exercise intervention is considered an essential component of NAFLD treatment, however; there are a limited number of published articles showing the effects of exercise training in the management of NASH. In addition, the physiological effect of exercise has still not been clarified because NASH is accompanied by metabolic problems such as obesity and T2DM. This study, it is aimed to bring innovation to the literature in understanding the physiological effects of exercise for this disease group by examining the effects of resistance exercise training in addition to aerobic exercise on intrahepatic lipid content, liver functions, inflammatory markers, muscle strength, functionality, and biopsychosocial status in individuals with NASH diagnosis who do not have an additional metabolic problem.
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated...
NASH - Nonalcoholic SteatohepatitisCirrhosis1 moreThis is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.
FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis...
Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisA Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe...
Non-alcoholic SteatohepatitisHepatic Impairment1 moreThe goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
Effect of Timed-Restricted Eating on Metabolic Health
ObesityNon-Alcoholic Fatty Liver Disease1 moreWe aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With...
SteatohepatitisThe purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.
A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH)...
Non-alcoholic SteatohepatitisThis Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A and B and in participants with a history of NASH or presumed NASH in Part C.
Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
Time Restricted FeedingExercise3 moreIn Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.
Hepatic Energy Fluxes in NASH and NAS Patients
NASH - Nonalcoholic SteatohepatitisNAS3 moreDiseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.
Dapagliflozin Efficacy and Action in NASH
Nonalcoholic SteatohepatitisThis is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.