A Prospective Study of Cold Exposure in Patients With MASH

概要

This prospective, single-center, single-arm exploratory study aims to evaluate the safety, feasibility, and potential metabolic and hepatic effects of repeated cold exposure in patients with metabolic dysfunction-associated steatohepatitis (MASH). A total of 11 participants with MASH will undergo cold exposure using a water-perfused cooling suit once daily for approximately 120 minutes over a 3-month intervention period. Liver fat content, liver function, lipid metabolism, body weight, and body mass index will be assessed before and after the intervention. Liver fat content will be evaluated by magnetic resonance imaging proton density fat fraction (MRI-PDFF), and blood tests will include alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglycerides (TG), and total cholesterol (TC). Liver ultrasound or liver stiffness-related measures and noninvasive fibrosis scores will also be evaluated when available. Safety, tolerability, adherence, and cold-related adverse events will be monitored throughout the study.