Clinical Research Directory

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.

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