186 Clinical Trials for Various Conditions
It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.
A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.
One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity and \~8 million of these individuals have a progressive form of the disease, non-alcoholic steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a prelude to the development of end-stage liver disease. The study of NAFLD has been limited by several factors, including the difficulties associated with studying liver metabolism in vivo in humans. Our group has pioneered new methods that use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this study, these noninvasive methods will be used to characterize and compare the metabolic alterations that accompany bland steatosis and NASH and test the hypothesis that detects if hepatic mitochondrial metabolism contribute to both disorders. Such characterization is fundamental to establishing a rational approach to the prevention and treatment of NAFLD and may provide simple, non-invasive methods to differentiate benign and progressive forms of NAFLD. This proposal will be addressed via separate isotopic studies occurring at different time points during a prolonged fast. In subjects with NAFLD, these studies will be carried out before and after treatment with Vitamin E or placebo. Healthy subjects will participate in initial baseline studies only without Vitamin E or placebo intervention. The study is designed to harness the physiologic changes that occur with short- and long-term fasting to provide a rapid and cost-effective method to accomplish the aims of the application.
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
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.
The main aim of the study is to discover the mechanisms underlying the pathophysiology of NAFLD in obese youth.
The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic fatty liver disease (NAFLD) is a global health concern with a suspected increasing prevalence due to the rise in obesity and diabetes mellitus. The vast majority of patients will have isolated steatosis or steatosis with mild inflammation that is very unlikely to progress in severity. However, about 25% of patients with NAFLD have non-alcoholic steatohepatitis (NASH), the more aggressive form of the disease that is associated with fibrosis progression and potential risk for cirrhosis and end-stage liver disease complications. Additionally, multiple studies have demonstrated an association between NAFLD and the presence of coronary artery disease by either coronary CT angiography (CCTA) or coronary artery calcium (CAC) score. Cardiovascular disease is the most important cause of mortality in patients with the entire spectrum of NAFLD. In the era of advanced imaging and functional vascular assessment it is possible that novel risk assessments are poised to refine overall prognostic estimation in this population. Multiple analyses have suggested that NAFLD is an independent and strong predictor of significant CAD independent of cardiovascular risk factors, including a significant burden of high risk CCTA findings in one analysis of symptomatic patients in the emergency department. Given the multiple metabolic derangements inherent in the NAFLD population, endothelial dysfunction is also an important contributor to global cardiovascular dysfunction. Furthermore, data suggests that patients with NAFLD may be at increased risk of adenomatous polyp formation and colorectal adenocarcinoma. In addition, it is suboptimal to require a liver biopsy to diagnose NASH. Recent imaging advances have made it possible to assess liver fibrosis but have yet to be fully studied in NAFLD. The purpose of this study is to assess the current prevalence and severity of NAFLD in adult subjects. Secondary endpoints include correlation to new vascular function (cine scan of the abdominal aorta) and echocardiographic imaging modalities available at BAMC and to circulating biomarker panels as well as to determine the prevalence and severity of CAD by multidetector coronary CT angiography with subject outcomes being monitored prospectively. Additionally, correlation of NAFLD diagnosis to colonoscopy findings will be performed.
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body).
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage liver disease. Weight loss, particularly if gradual, may lead to improvement in liver histology. Unfortunately, few patients in the pediatric population are willing to follow these recommendations and achieve weight loss. Medical treatment directed specifically at the liver disease has only recently been investigated and approved in patients with NAFLD. The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators of pathways that participate in decreased production and break down of triglycerides and fatty acids in the liver. The investigators hypothesize that children with obesity related NAFLD will normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver disease.
Prospective determination of the prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)in a primary care setting using ultrasound and percutaneous liver biopsy.
The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to have NAFLD or nonalcoholic steatohepatitis (NASH)-related cirrhosis and will also invite adult participants from the prior NAFLD Database and related studies (PIVENS trial and TONIC trial) to enroll in the NAFLD Database 2. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.
Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. The investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. The purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of NAFLD.
The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).
Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver. The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase the operative complications of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduce complications of surgery. Most bariatric surgery programs use a conventional low fat, calorie restricted diet during the preparation phase for surgery. The investigators will compare the effects of the low carbohydrate versus the low fat diets on weight loss, reduction in liver fat content, and liver size. These results will provide new clinical insights into the optimal dietary intervention to make bariatric surgery safe and effective for the increasing numbers of patients opting for this aggressive therapy for morbid obesity. Patients approved for bariatric surgery by the University of Michigan Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to 1200 calorie low fat or low carbohydrate, 8-week study diet. All the food for this study will be provided for free by the study team. Participants will be required to meet with the study team weekly to pick up study food and for a nutritional consult. These visits will occur in the eight weeks preceding the patient's bariatric surgery procedure. During the bariatric surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat content.
The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.
Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and into the stomach to image various parts of the body. A small piece of tissue called a biopsy, of your liver nay be obtained by this method. the tissue (biopsy) would be obtained by inserting a small needle through the lining of the stomach into the liver. Consideration for this biopsy is because there may be extra fat stored within the liver. In some people who drink too much alcohol, extra fat may be stored in the liver, however, in some people who don't drink too much alcohol, this may also occur and is called :non-alcoholic fatty liver disease or NAFLD. Over time, this extra fat may lead to liver irritation and scar tissue called cirrhosis. If NAFLD is detected early enough, then treatment with medications, losing weight, or dietary changes may help avoid cirrhosis. the purpose of this study is to learn about whether doctors can obtain the biopsy from the liver by a new method. The biopsy of the liver allows the doctors to look for any signs of scar tissue or inflammation from any cause.
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG) (primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with treatment will be performed.
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.
The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects with nonalcoholic fatty liver disease (NAFLD).