Clinical Research Directory

Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

The purpose of this research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.

An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD. In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.

The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis

A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.

Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD

MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.