Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
HIV InfectionsFatty LiverThe purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With...
Nonalcoholic Fatty Liver DiseaseThe 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.
Integrated Approaches for Identifying Molecular Targets in Liver Disease
Alcoholic Liver DiseaseNon-Alcoholic Fatty Liver Disease3 moreTo provide a framework for successful clinical trials testing novel targets for therapy in liver disease. To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression. Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.
Losartan for the Treatment of Pediatric NAFLD
NAFLD - Nonalcoholic Fatty Liver DiseaseA multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in...
Nonalcoholic Steatohepatitis (NASH)This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
SRMA of the Effect of Soy Milk vs Cow's Milk on Cardiometabolic Outcomes
Cardiovascular DiseasesLipid Disorder2 moreDairy consumption has shown associations with decreased incidence of cardiometabolic diseases. With the growing interest in plant-based eating, and the mounting evidence for the cardiovascular benefits of plant forward diets, national dietary guidelines have pivoted away from promoting exclusive daily dairy consumption. Soymilk is the most nutritionally comparable non-dairy plant-based alternative to cow's milk. Although the DGA, Health Canada, and various pediatric associations recognize fortified soymilk as the only non-dairy alternative equivalent to cow's milk and it can carry an approved health claim for coronary heart disease risk reduction based on the soy protein that it contains, soymilk is classified by the NOVA classification as an ultra-processed food (the opposite of the classification of cow's milk as an unprocessed or minimally processed food). To be an acceptable iso-sweet alternative to cow's milk, soymilk is also often sweetened with sucrose, which is designated as an added sugar, whereas the lactose that sweetens cow's milk is not (despite lactose in cow's milk being present in quantities that are double that of sucrose in soymilk products designed to be iso-sweet analogues of cow's milk). With near universal recommendations from major public health authorities to reduce the intake of both ultra-processed foods and added sugars and the FDA proposing to update its "healthy" claim criteria to limit added sugars, the role of soymilk as a "healthy" non-dairy alternative to cow's milk is in serious question. The effect of soy protein on other cardiometabolic outcomes is also unclear. To address this question and better inform health claims and guideline development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein as soy milk, in substitution for cow's milk, on various intermediate cardiometabolic mediators.
The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease
Non Alcoholic Fatty Liver DiseaseThe purpose of this study is to examine whether CPAP therapy can reduce or eliminate hepatic fat accumulation in obese children and adolescents.
Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis...
Nonalcoholic SteatohapatitisThe purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.
The Effect of Probiotics on Non Alcoholic Fatty Liver Disease
Liver DiseaseNonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of chronic liver disease in the general population in the Western World. In advanced stages of NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of probiotics as a therapeutic strategy for this disorder.
Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
Liver FibrosisSteatohepatitis1 moreThis study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage. Although there are a number of possible causes for these elevations, such as infections with a hepatitis virus, antiretroviral medications alone can lead to the elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign of progressive liver damage. HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients who have had liver biopsies performed in the past may be eligible for participation. Participants undergo the following tests and procedures over a 12-month period: Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This test measures how high the patient's blood sugar and insulin levels rise after drinking a standard glucose load. Transient elastography: This ultrasound test uses vibration (sound waves) to measure liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver. Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before the CT scan. A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner. Liver biopsy: This test removes a small sample of liver tissue for microscopic examination, particularly for evidence of fibrosis. The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver. Patients may be given a sedative for the procedure. Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history, physical examination and blood tests. Patients may participate in an additional 4-year follow-up, during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy.