Clinical Research Directory

Accurate Point of Care Liver Disease Diagnostics (Phase 2)

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

Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, efficacy of the Unani compound formulation Qurse Revand compared to a placebo in adult participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Prevalence and Clinical Significance of Hematological Abnormalities in Patients With Clinically Diagnosed Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Case-Control Study

this study aims to investigate the prevalence of hematological abnormalities among patients with clinically diagnosed MASLD, evaluate their clinical correlates, and examine their association with non-invasive fibrosis scores. The findings may improve risk stratification and facilitate early identification of patients who require closer monitoring or further hepatological assessment.

AGED Diagnostics Clinical Validation Study

Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the assessment of liver fibrosis (scarring). MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) that can lead to advanced liver disease, cirrhosis and liver-related complications. This prospective, observational study will enroll approximately 400-500 patients with suspected MASLD who are undergoing liver biopsy as part of their clinical care. Researchers will collect blood samples and relevant medical information from participants at multiple clinical sites. The blood samples will be analyzed using advanced DNA sequencing technology to measure DNA methylation, a biological marker that may provide information about liver health. The study will evaluate how accurately the investigational blood tests distinguish MASH from simple steatosis (fat accumulation in the liver without MASH) and identify different stages of liver fibrosis. Blood test results will be compared with liver biopsy findings. The results will be used to select and validate the most accurate prediction models for future clinical utility studies. The long-term goal is to develop noninvasive blood tests that may help healthcare providers identify patients with MASH and liver fibrosis earlier and guide appropriate clinical care.

External Transportability Validation, Implementation Readiness, and Outcome Association of the TransHepMet-Mort Liver Metabolic Mortality Risk Model

Study data were derived from existing electronic health records at our hospital's health examination center between January 1, 2018, and December 31, 2024. These records encompassed fatty liver-related checkups, liver ultrasound/elastography, laboratory tests, anthropometric measurements, and medical histories. Following ethical approval, these datasets were linked to mortality registry, hospitalization records, and liver-related events. This study does not alter participants' past or current clinical pathways, introduces no new examination items, and requires no additional follow-up visits.Concurrently, this study serves as an external implementation evaluation of a clinical prediction model. The original model was derived from prior analyses of NHANES, CHARLS, and VCTE datasets. Rather than re-developing the primary model within the hospital data, this study focuses on evaluating the real-world implementation readiness of the existing model, conducting phenotypic validation, and performing conditional outcome verification. The application of the model within the hospital cohort is strictly limited to research purposes and will not serve as the sole baseline for clinical diagnostic or therapeutic decision-making.

Detecting Liver Fibrosis in Patients At-risk

The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption. The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.

Effect of a Low AGE Diet on Liver Function in Adults With Fatty Liver.

Introduction. Advanced glycation end products, known as AGEs, are compounds that form when sugars bind uncontrollably to proteins, fats, or DNA. This occurs naturally in the body, but they also form in food, especially when cooked at high temperatures. Techniques such as grilling, frying, browning, or toasting increase AGE formation in food. Processed foods or those dry-heated above 160 °C often contain many AGEs. When we consume them, about 10% of these AGEs can be absorbed by the body. Among the most studied types of AGEs are CML (N-6-carboxymethyl lysine) and pentosidine; these compounds have been found in the blood and liver of people and animals with metabolic hepatic steatosis (METS), a disease characterized by the accumulation of fat in the liver. When the body doesn't respond well to insulin and there are problems processing fats and sugars, the formation of AGEs is favored, which in turn can damage the liver. AGEs act by binding to receptors called RAGE; this binding activates various signals within cells that promote inflammation. Both RAGE and its soluble form (sRAGE) are important in metabolic syndrome (MetS). The AGE-RAGE interaction can contribute to the accumulation of more fat in the liver and help the disease progress to more severe stages. The aim of this study is to evaluate whether a low-AGE diet improves liver function and reduces the amount of fat in the liver in adults with fatty liver not related to alcohol consumption. Our hypothesis is that implementing a low-AGE diet will improve liver function and decrease the degree of steatosis in adults with fatty liver not related to alcohol consumption. A clinical trial will be conducted comparing two groups. Forty-eight people who consume high amounts of AGEs (more than 8,000 KU) and have fatty liver of any grade will participate. Participants will be randomly assigned to one of two groups: one will follow an AGE-restricted diet, and the other will maintain their usual diet, for 12 weeks. Before and after the study, the following measurements will be recorded: weight, height, waist circumference, hip circumference, abdominal circumference, and blood pressure. Fasting blood samples will also be taken to measure glucose (blood sugar), insulin, triglycerides, total cholesterol, HDL, LDL, AGE levels, glycated hemoglobin (which measures the average blood sugar level), and tests to evaluate liver function.

GLUT-F Improves MASLD Liver Function

This randomized, double-blind, placebo-controlled, two-period crossover study evaluated the effects of GLUT-F, a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E delivered with Enterosoma® technology, in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants received GLUT-F and placebo for 3 months each, separated by a 1-month washout period. The study assessed changes in hepatic steatosis, liver enzymes, metabolic parameters, inflammatory markers, and liver function measured by ultrasonography and the \^13C-methacetin breath test.

Combination of CXD and Restrictive Ketogenic Diet Against MASLD

This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial. A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha Lipid-Reducing Formula combined with a restrictive ketogenic diet. The trial duration consisted of 8 weeks of treatment followed by 8 weeks of follow-up. During the trial, participants adhered to dietary calorie control and moderate exercise as instructed in health education, self-reported their height, weight, waist-to-hip ratio, and other general parameters, and had weekly blood ketone level monitoring. Liver ultrasound, fasting blood glucose, lipid profiles, blood ketones, liver function tests, serum creatinine, urea nitrogen levels, and scores on the Traditional Chinese Medicine Syndrome Scale were measured before treatment initiation and at the end of the 8-week treatment period.

Deep Learning for Liver Fibrosis Triage in MASLD Using Longitudinal Electronic Health Records

This study looks at a new computer program called NIMIT-AI (Neural Inference for Metabolic-liver Integrated Trajectories, Artificial Intelligence) that helps doctors find liver scarring early in patients with fatty liver disease. Fatty liver disease, also called metabolic dysfunction-associated steatotic liver disease (MASLD), is a common condition where fat builds up in the liver. Over time, this can cause scarring (fibrosis). Finding scarring early helps doctors treat it before it gets worse. Right now, doctors use a blood test score called FIB-4 to check for scarring. But this score misses many patients and cannot be calculated when blood test results are incomplete. NIMIT-AI works differently. It reads a patient's blood test results over multiple visits, not just one visit, to spot patterns that suggest liver scarring. It was tested on 969 patients seen at Siriraj Hospital in Bangkok, Thailand between 2018 and 2022. In testing, NIMIT-AI found liver scarring more accurately than FIB-4. It also worked even when some blood test results were missing, which happens often in real clinics. This study did not ask patients to do anything extra. It used health records that were already collected as part of regular care.

Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity

The objective of this study is to demonstrate that an \< or equal to 8-hour time-restricted eating (i.e., fasting for at least 16 hours every day), not focusing on reducing caloric intake, reduces intra-hepatic fat in patients with obesity and Metabolic dysfunction-Associated Steatotic liver Disease (MASLD).

UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers

Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort. Study details include: * Study duration will be up to 36 months including the screening period. * Intervention will be up to 16 weeks. * Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.

Temporal Eating Patterns and Metabolic Health

Obesity and its related health problem, like fatty liver disease and type 2 diabetes, are major health problems worldwide and can lead to serious illness and reduced quality of life. Most advice focuses on eating fewer calories and increasing physical activity, but new research suggests that when we eat may also matter. Late meals can disrupt blood sugar control, how the body processes fat, and hormone balance. However, it is not fully understand how meal timing affects people who may be more at-risk. For example new mothers face disrupted sleep, which can lead to eating later in the day. People with fatty liver disease may have eating patterns that unintentionally worsen their condition. To explore this, the study will include the following groups; 1. First-time mothers in early motherhood, and women who do not have children. 2. People with fatty liver disease along with people of similar age, sex, and weight who do not have the condition. The aim of the study is to compare meal timing habits between these groups. All participants will complete a 3-day diet diary and a questionnaire about eating habits, sleep, lifestyle, and daily routines. Some participants may opt to complete an optional body composition check using a mobile app. A smaller subset of volunteers will take part in additional assessment, including a fasting blood sample, basic measurements (such as height, weight, and waist size), a body scan to measure fat and muscle. They will also wear a small device to track their blood sugar and another to monitor sleep and activity for 14 days. This study will increase the current understanding on how eating patterns and daily routines differ in these groups, and may help improve future advice on healthy lifestyles.

Identification and Characterization of At-risk MASLD in Turkish Adults

MASLD is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). MASLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from steatosis to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% steatohepatitis (MASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with MASLD have no or few, mainly specific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, the majority of MASLD patients are currently not detected due to the lack of non-invasive methods to diagnose MASLD. To date, the prevalance of MASLD in Turkey among subjects at risk, and its relation to common comorbidities such as obesity, T2DM and CVD is not clear. Therefore, identification of MASLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health. Within this context, this study aims to detect prevalence of MASLD among risk groups. Also, the risk factors related to MASLD etiology and progression, such as overweight, obesity, T2DM, CVD, diet and physical activity will be studied to have a better understanding of their presumed causal relationship with MASLD. This study is designed to study the prevalence of and risk factors associated with MASLD in adult populations at-risk of MASLD. Participants will undergo liver assessments via vibration controlled transient elastography. Lifestyle, demographic, and biochemical data will be collected.