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NCT07530419
Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients. This prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.
NCT07518784
This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use. In this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations. Study participants will be asked to complete a one-time visit which includes: * LiverScope exam * MR exam * FibroScan exam (optional) * Blood draw * Completion of study questionnaires
NCT07480811
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in childhood is becoming increasingly prevalent, paralleling the rise in obesity rates, and has become the most common chronic liver disease in the pediatric population. MASLD is associated with metabolic mechanisms such as insulin resistance, dyslipidemia, oxidative stress, and inflammation, and can progress to serious complications like steatohepatitis, fibrosis, and cirrhosis in later stages. Currently, pharmacological treatments for managing MASLD are limited, and lifestyle modifications, particularly dietary interventions, stand out as the primary approach for preventing and treating the disease. In this context, the composition of macro and micronutrients plays a critical role in the development and progression of hepatic steatosis. Within this framework, the Dietary Approaches to Stop Hypertension (DASH) diet is a balanced eating pattern that encourages the consumption of vegetables, fruits, whole grains, legumes, low-fat dairy products, fish, poultry, and healthy fat sources, while limiting sodium, saturated fat, sugary foods, and processed meat products. Similar to the Mediterranean diet, the DASH diet is a promising approach for conditions like metabolic syndrome and MASLD due to its anti-inflammatory potential, its reducing effect on oxidative stress, and its properties that enhance insulin sensitivity. Furthermore, thanks to its high fiber content, it contributes to balancing the gut microbiota and supports the production of short-chain fatty acids (SCFAs), which in turn have positive effects on liver and metabolic health. Evaluated in terms of fat intake, the DASH diet's emphasis on foods rich in n-3 fatty acids (such as fish and walnuts) provides an anti-inflammatory effect, while limiting saturated and trans fats offers an important strategy for reducing hepatic fat accumulation. Additionally, restricting the consumption of added sugars and fructose may be effective in preventing hepatic steatosis by suppressing lipogenesis processes. In light of all these scientific findings, considering the impact of dietary patterns on the development and progression of MASLD, appropriately structuring the diet is critically important for protecting liver health in children. Accordingly, an anti-inflammatory, antioxidant, and metabolically balanced DASH dietary model is considered an effective and applicable approach in the management of pediatric MASLD. Within the scope of this study, the effects of implementing the DASH diet in children with MASLD on clinical and metabolic parameters such as liver enzymes, degree of hepatic steatosis, insulin resistance, lipid profile, and inflammatory markers will be evaluated compared to a control group. Additionally, by examining the relationships between these parameters and quality of life as well as dietary adherence, the potential therapeutic role of the DASH diet in the management of pediatric MASLD will be elucidated.
NCT07440511
Measurement of spleen stiffness (SSM) has shown potential as a complementary tool to liver stiffness measurement (LSM) for the assessment of portal hypertension in patients with MASLD, particularly in the setting of compensated advanced chronic liver disease (cACLD). The 100-Hz probe for SSM, developed more recently, improves the accuracy of spleen stiffness measurements by better capturing the specific characteristics of the splenic parenchyma. This method has been shown to correlate well with HVPG, the gold standard for the assessment of portal hypertension, and has demonstrated good predictive value for the detection of high-risk varices, which are indicative of advanced liver disease. The correlation between SSM and other clinical markers, such as spleen size and platelet count, has proven to be strong, further supporting its utility in assessing disease progression. This makes SSM a promising non-invasive tool for early detection and risk stratification in MASLD, which is crucial for preventing progression to more severe stages such as cirrhosis or hepatocellular carcinoma. In conclusion, the combined use of LSM and SSM shows great potential for improving the non-invasive diagnosis and monitoring of MASLD, providing an efficient alternative to more invasive methods such as liver biopsy and HVPG. This evidence has led to the inclusion of SSM use in clinical guidelines for the management of patients with chronic liver disease. Nevertheless, further studies are needed to confirm these findings and to refine clinical protocols, potentially allowing earlier intervention and improved management of patients with MASLD and its complications.
NCT04555434
A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and improve metabolic and hepatic outcomes in MASLD; however, clinical evidence regarding next-generation probiotic strains remains limited. This study was designed to evaluate the effects of three next-generation probiotic strains-Lactobacillus delbrueckii subsp. lactis (LL001), Lactobacillus helveticus (LH001), and Pediococcus pentosaceus KID7 (PPKID7)-on liver function parameters and gut microbiome composition in patients with MASLD. We conducted a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 110 adult patients diagnosed with MASLD were screened for eligibility. Eligible participants were randomly assigned to receive one of the three probiotic formulations (3 capsules per day, total 9×10⁹ CFU) or placebo for 8 weeks. All participants received concomitant silymarin during the intervention period. Clinical assessments, serum samples, and stool samples were collected at baseline and at the end of the intervention. Liver function parameters were predefined as the primary outcome measure. Secondary outcomes included changes in anthropometric parameters, serum metabolic markers, gut microbiota composition assessed by 16S rRNA gene sequencing, and lipidomic profiles derived from serum and fecal samples. Compliance was monitored throughout the study period. The study protocol was approved by the institutional review board, and written informed consent was obtained from all participants prior to enrollment.
NCT07366463
Metabolic dysfunction associated Steatotic Liver Disease (MASLD) is frequently complicated by cardiometabolic (CMR) comorbidities, and prognosis is substantially influenced by acute cardiovascular events (ACE). Although several pharmacological approaches target CMR risk factors, lifestyle modification remains the cornerstone of management. However, adherence to dietary behavioral prescriptions is often poor, and the influence of sociodemographic determinants on compliance remains unclear. Moreover, the long-term real-life impact of behavioral and motivational support in MASLD is insufficiently characterized. This randomized controlled trial aims to evaluate the effectiveness of a multidisciplinary management (including Hepatological counseling, Nutrition intervention, and Psychological support) in improving clinical MASLD outcomes, by increasing adherence to specialist-tailored recommendations.
NCT06318169
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
NCT06843148
Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver. The goal of this mechanistic study is to investigate metabolic response in patients aged 50 to 80 years with non-alcoholic fatty liver disease, after niacin (vitamin B3) treatment. The main questions it aims to answer are: * Does Niacin lower the fat deposition in the liver? * Does Niacin raise White Adipose Tissue storage of dietary fatty acids? Researchers will compare Niacin to a placebo (a look-alike substance that contains no drug) to compare the metabolic response. Duration of study per participant: Up to 28 weeks
NCT07386665
Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate how performing exercise at different times of day (morning vs. evening) affects liver fat, cardiometabolic health, and gut microbiota in postmenopausal women. Participant Population/Health Conditions: The study will involve 63 sedentary postmenopausal women (aged 45-75) diagnosed with metabolic dysfunction-associated steatotic liver disease. Main Questions: The main questions this study aims to answer are: * Does morning exercise reduce hepatic fat more effectively than evening exercise? * How does time-of-day-specific exercise influence cardiometabolic markers? * Do changes in gut microbiota contribute to the metabolic effects of exercise timing? Participants Will: Be randomized into one of three groups: morning exercise, evening exercise, or a usual-care control group. Follow the assigned regimen for 12 weeks. The exercise groups will perform supervised aerobic and resistance training three times per week. Provide blood, stool, and imaging data before and after the intervention to determine the effects of the intervention. Comparison Group: Researchers will compare the effects of morning vs. evening exercise (and usual care) on hepatic fat reduction and cardiometabolic improvement, as well as changes in gut microbiota.
NCT05395481
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on MASLD and assessment of resolution of liver fibroinflammation. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 visits in parts A and B.
NCT06868992
The main research hypothesis is that alterations in the communication between the endoplasmic reticulum (ER) and the mitochondria at contact sites called mitochondria-associated membranes (MAMs) occurs in different hepatic cell types of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD) and is involved in the progression towards MASH and could also influence the process of improvement of MASH. This study aims to investigate the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) in liver cells and peripheral blood mononuclear cells (PBMCs) in patients undergoing bariatric surgery. The primary objective is to analyze MAMs alterations in hepatocytes in MASH patients compared to non-MASH patients. Secondary objectives include evaluating the correlation between MAMs in PBMCs and liver cells and assessing MAMs changes post-bariatric surgery.
NCT07321925
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
NCT07313007
Metabolic dysfunction-associated steatotic liver disease (MASLD) encompasses a spectrum of liver disorders ranging from simple steatosis-a relatively benign and non-progressive condition-to metabolic dysfunction-associated steatohepatitis (MASH), characterized by hepatocellular inflammation. MASLD is now the leading cause of chronic liver disease worldwide, affecting approximately one in three adults, particularly those with obesity or type 2 diabetes. Recent studies have highlighted a strong interconnection between the gut microbiota, the liver, metabolism, and the immune system, collectively referred to as the gut-liver axis. Alterations in the gut microbiota are observed at all stages of MASLD, and several microbial metabolites-such as trimethylamine, bile acids, short-chain fatty acids, and ethanol-have been implicated in disease progression. Emerging evidence points to a role for gut-derived metabolites of tryptophan (Trp) and phenylalanine (Phe), including phenylacetic acid (PAA), 3-(4-hydroxyphenyl)-lactate (HPL), and phenyllactate (PL). These compounds have been associated with the severity of MASLD, particularly with hepatic steatosis and fibrosis. Elevated plasma levels of aromatic amino acids (AAAs), such as L-phenylalanine and L-tyrosine, are also correlated with increased hepatic fat content. A newly identified Phe-derived metabolite, N-acetyl-phenylalanine (NAPA), together with PAA, HPL, and PL, has been shown to correlate with hepatic steatosis. These metabolites can induce steatosis both in vitro and in vivo, acting through the disruption of endoplasmic reticulum-mitochondria interactions. They therefore represent potential new therapeutic targets. These four metabolites of interest (NAPA, PAA, HPL, PL) can be produced both by gut bacteria and through endogenous human metabolism. Positive correlations between plasma NAPA concentrations and specific bacterial species have been observed, although the responsible taxa remain to be identified. HYPOTHESIS We hypothesize that the gut microbiota of MASLD patients produces aromatic amino acid-derived metabolites, contributing to the elevated plasma concentrations observed in these patients Two complementary strategies will be used : Human Microbiota Culture and Fecal Microbiota Transplantation
NCT06735924
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
NCT07216859
The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and/or cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs). The main question it aims to answer is to: 1. Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment. 2. Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.
NCT07097506
The goal of this clinical trial is to determine whether ingestion of a ketone ester drink helps improve liver health and blood glucose control. Ketones are a type of energy source made by the body during times of weight loss, low carbohydrate intake and starvation. People enrolled in this study will be randomly assigned (by chance, like the flip of a coin) to one of two groups: Group 1: Ketone ester drink consumed daily for 6 weeks. Group 2: Placebo drink consumed daily for 6 weeks.
NCT07090083
This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly 4 times increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient poor foods (e.g., sugar sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.
NCT07133854
Steatotic liver disease associated with metabolic dysfunction (MASLD) is a disease caused by excess fat storage in the liver. Excessive fat delivery to the liver and MASLD typically occurs in people with abdominal obesity and type 2 diabetes. Type 1 diabetes (T1D) is also associated with a marked increase in the release of fat from adipose tissues and MASLD is increased in T1D and significantly increases the risk of heart, kidney and eye diseases.
NCT07114926
This study investigates the effectiveness of Taiwanese green propolis in reducing blood lipids and body fat in sub-healthy individuals. The study design follows a parallel, double-blind, randomized assignment approach, dividing participants into an experimental group (propolis) and a control group (placebo). Researchers explained the study plan to participants, and after obtaining signed informed consent, participants were randomly assigned using a web-based program that generated random serial numbers. The randomization was stratified by gender (male-to-female ratio of 1:1) and physiological age groups (maturity, middle age, menopause, post-menopause, and old age). Serial numbers and group assignments were sequentially encoded and placed in opaque, consecutively numbered envelopes. After obtaining consent, researchers opened the sealed envelopes in order and assigned participants to either the experimental group (propolis) or the control group (placebo), with 30 participants in each group. The experimental group received Taiwanese green propolis (which can be stored at room temperature) in capsule form, containing 500 mg/ml of propolis extract per capsule. Participants took two capsules before breakfast and two before dinner, totaling four capsules per day for 12 weeks. The control group received a placebo with the same dosage and administration method. All participants were instructed not to deliberately change their daily diet or exercise routines during the study. To assess adherence, participants recorded their daily propolis capsule intake. Additionally, the Health Belief Model questionnaire and the EQ-5D-5L quality of life questionnaire were used to evaluate whether the intervention with propolis, along with dietary and exercise education, contributed to increased awareness of health behaviors and improvements in quality of life. The primary outcomes of the study include changes in blood lipids, body fat, blood glucose levels, liver fat, and liver fibrosis. The secondary outcomes focus on the correlation between health behavior awareness and quality of life. Keywords: Taiwanese green propolis, sub-health, blood lipids, body fat, Health Belief Model, quality of life.
NCT06493253
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).