Active clinical trials for "Liver Diseases"

This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).

Arterial stiffness and endothelial dysfunction present in metabolic associated fatty liver disease (MAFLD) confer increased cardiovascular risk, which represents the leading cause of mortality in this group of patients. Mechanisms involved in the cardiovascular complications of MAFLD have recently been found to also affect cerebral blood flow altering cerebral hemodynamics in MAFLD subjects. These alerations can be detected through transcranial Doppler, which measures markers of cerebrovascular vasoconstriction, which indicates cerebrovascular autoregulation.16 These abnormalities are related to vascular disease in MAFLD, which plays an essential role in ischemic stroke and cognitive impairment, which explains why MAFLD patients had lower scores on cognitive function tests.17 Nonetheless, there are no studies evaluating the effect of lifestyle interventions (specifically exercise) on cerebral hemodynamics in patients with MAFLD, however, it has been shown that in other pathologies that share pathophysiological similarities with NAFLD there are beneficial changes in this outcome. An example of the above is chronic heart failure and liver cirrhosis, where physical exercise attenuates the inflammatory cascade (decrease in IL6, IL8, IL12, TNFa), and decreases the activation of the renin-angiotensin system with a direct effect on endothelial function improvement. Our research group also documented that a 12-week physical training program acts on this mechanism and has a beneficial effect on cerebral hemodynamics evaluated by transcranial Doppler in patients with liver cirrhosis, which leads to an improvement in neuropsychometric tests.18 Improvement in the previously described pathways through a 16-week physical training program in MAFLD patients could potentially improve alterations in cerebral blood flow, cognitive function, endothelial function, body composition, and the degree of liver steatosis and fibrosis. This outcome has never been assessed in MAFLD patients undergoing exercise. In addition, although there are studies that demonstrate the impact of diet and exercise, most have evaluated these interventions individually, which represents a limitation when implementing them as a multidisciplinary intervention. Therefore, our hypothesis is that a 16-week physical training program will improve cerebral hemodynamic parameters in patients with metabolic-associated fatty liver compared to a control group without a physical training program.

Obesity has been increasing all over the world. This has lead to a significant increase of a liver disease in children called non-alcoholic fatty liver disease (NAFLD). NAFLD is a liver disease that ranges from excess fat being stored in the liver to an inflamed and fatty liver with fibrosis to cirrhosis. NAFLD is thought to be caused by changes in energy, fat and carbohydrate metabolism induced by diets high in in processed foods. Sugary (especially high fructose corn syrup or HFCS) and fatty foods in processed foods have been shown to produce more insulin resistance, a factor that is thought to cause a fatty liver. Currently the main treatment for NAFLD is weight loss. However, it unknown the best way to achieve this. The investigator has shown previously that adolescents with NAFLD eat a lot of fatty and sugary foods, and that when they decrease the amount of foods they eat that contain HFCS, experience some improvements in insulin resistance and liver dysfunction even when they don't lose weight. The plan is to compare and contrast how two different diets (high vs low HFCS containing diets) may affect how much fat gets deposited in the liver and whether or not a lower diet in HFCS can help decrease liver damage in adolescents with NAFLD.

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

This is a Phase 1 study designed to assess the effect of hepatic insufficiency on the PK of pacritinib by study of 14-day BID dosing of pacritinib in subjects with moderate and severe hepatic impairment compared to healthy matched control subjects with normal liver function. Safety and tolerability of multiple day dosing of pacritinib in the subject populations will also be evaluated.

The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.

To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.

The design of the Phase 2 clinical trial includes the following elements: Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S. Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks. The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FebroScan is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response. Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).

The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.