Clinical Research Directory

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

This study aims to test the utility of Velacur ultrasound as a non-invasive, rapid, point of care diagnostic tool for detecting the presence and amount of hepatic steatosis in children and adolescents aged 2 - 20 years.

Feasibility of the Paso Program for Patients With Metabolic Dysfunction Associated Steatotic Liver Disease

The purpose of this study is to learn whether the Paso weight loss program is feasible for Mexican and Central American patients with fatty liver disease. In addition, the investigators will also look at whether the program improves weight loss, fatty liver disease, physical activity, diet, and family support among patients.

Human Models of Selective Insulin Resistance: Pancreatic Clamp

This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.

Prognostic Model for MASLD Related Cirrhosis

This study enrolled 228 patients with MASLD-related cirrhosis confirmed by histopathology or clinical diagnosis. Follow-up was conducted every 3-6 months. The primary endpoint was cumulative incidence of liver-related events (including decompensation events, hepatocellular carcinoma, liver transplantation, and liver-related mortality) and all-cause mortality. Secondary endpoints included cumulative incidence of metabolic events and changes in non-invasive fibrosis markers.

Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of chronic liver disease worldwide and a significant public health issue. MASLD may progress to liver cirrhosis and/or hepatocellular carcinoma. Although previous evidence suggests that aspirin has antisteatotic and antifibrotic effects on the liver, a randomized controlled trial assessing long-term efficacy and safety of aspirin in MASLD patients has yet to be conducted. This study aims to conduct a randomized controlled trial to evaluate the efficacy of aspirin in treating MASLD.

Clinical Classification of MAFLD Based Liver Biopsy

Metabolic dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. It is closely related to the high incidence of cardiovascular-renal-metabolic syndrome and both liver and non-liver malignancies, posing a serious threat to public health. However, the diagnostic criteria for MAFLD are not unified globally, and the classification and staging still rely on liver biopsy for pathological assessment. The characteristics, mechanisms, and predictive indicators of liver and extrahepatic disease outcomes in MAFLD patients are not yet clear. The severe form of MAFLD, metabolic dysfunction-associated steatohepatitis (MASH), has been a hot and challenging area of research for non-invasive tests (NITs). However, serum markers, imaging examinations, and novel markers under development cannot replace liver biopsy for the diagnosis of MASH. Clinically, the disease outcomes of MAFLD mainly depend on metabolic cardiovascular risk factors and fibrosis staging. Both liver biopsy and NIT-diagnosed advanced fibrosis and cirrhosis can predict liver-related events and all-cause mortality risks in MAFLD patients. Artificial intelligence and machine learning methods can improve the consistency of pathologists in diagnosing MASH and fibrosis. The Agile score, which combines gender, T2DM status, AST/ALT ratio, platelet count, and liver stiffness measurement (LSM), can improve the diagnostic efficacy of advanced fibrosis and cirrhosis in MAFLD patients and the efficiency of predicting liver-related events. However, the predictive effect of fibrosis staging and its changes on liver cancer needs to be improved. There is a lack of high-quality research on early warning indicators for the incidence of CVD, chronic kidney disease, and non-liver malignancies in MAFLD patients. It is necessary to explore the role of conventional indicators such as low-density lipoprotein cholesterol, lipoprotein(a), uric acid, and high-sensitivity C-reactive protein, as well as multi-omics parameters, in the classification, staging, and risk prediction of MAFLD. MAFLD is an increasingly serious public health issue associated with a higher risk of liver-related events, cardiovascular-renal-metabolic syndrome, and malignancies. The prevalence of MAFLD in China is high, but the rate of standardized management is low. Even patients with the same classification and staging often have different clinical characteristics and outcomes. There is currently a lack of a clinical classification and early warning system for MAFLD that combines metabolic cardiovascular risk factors and NITs for different outcome risks.

COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease worldwide, currently affecting approximately 1-in-4 people globally. The prevalence is expected to rise further, driven at least partly by the epidemic of obesity and diabetes. MASLD is a condition of fat build-up in the liver that can progress to liver scarring which is associated with higher chances of death. Women are more than twice as likely to develop MASLD after menopause compared to before menopause, and previous research has shown that this may be caused by a lack of oestrogen. A lack of oestrogen is also believed to lead to harmful changes in adipose (body fat), which has an important role in the development of MASLD. Oestrogen contained in hormone replacement therapy (HRT) is an effective treatment for hot flushes and other problems in menopause. The popularity of HRT has increased dramatically in the United Kingdom in recent years, however the exact way in which it affects adipose and MASLD is unclear. The investigators will study how HRT affects the processes that drive MASLD in 10 women before and after using the treatment. This is a small-scale pilot study to understand feasibility of recruitment and test the procedures for a future, larger-scale studies. The investigators will recruit women who are about to begin HRT for the first time and perform the same tests for each participant before starting HRT, and after using HRT for 12-weeks. The participants will undergo meal testing including non-radioactive, stable isotopes, and blood and breath samples will be collected to measure fat processing. The total fat content of the liver will be measured using magnetic resonance imaging (MRI) scans. Adipose samples will be collected, fat metabolites will be measured and the distribution of fat around the body will be assessed using a dual energy x-ray absorptiometry (DEXA) scan. To find out how HRT affects these processes, the results from before and after using HRT will be compared. Understanding how HRT affects adipose and the liver may help reduce the development of MASLD in women after the menopause and improve their health and survival.

Pattern of Cardiac Arrhythmia in Patients With MASLD

Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients

Investigating Myosteatosis in Steatotic Liver Diseases

Steatotic liver diseases (SLD) are the most common chronic liver diseases worldwide. SLD are defined by an excessive liver lipid content (steatosis) of more than 5% of the total liver weight and includes 3 clinical entities : metabolic dysfunction-associated steatotic liver disease (MASLD), alcohol-related liver disease (ALD) and a mixed entity combining the two settings referred as MetALD. SLD are associated to extra-hepatic complications such as cardiovascular diseases, insulin resistance or muscle changes. Among the latter, myosteatosis, defined by an excessive muscle fat content, has been reported as a muscle change in MASLD occuring even in non-cirrhotic stages. Investigators will explore these muscle changes in SLD patients according to the severity of the underneath liver disease.