A Prospective Study of Cold Exposure in Patients With MASH

Condition(s) studied

Investigational drug(s) / intervention(s)

Water-Perfused Cooling Suit: Participants will receive repeated cold exposure using a water-perfused cooling suit with a target circulating-water temperature of approximately 22°C. The intervention will be performed once daily for approximately 120 minutes over a 3-month period. Each session will include a 10- to 15-minute adaptation period, during which the circulating-water temperature will be gradually reduced according to individual tolerance. The actual circulating-water temperature, exposure duration, tolerability, and adverse reactions will be recorded. Blood pressure, heart rate, body temperature, shivering, and subjective discomfort will be monitored during each session.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Liver Fat Content Assessed by MRI-PDFF — Baseline to 3 months after cold exposure intervention
  Change in hepatic fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to the end of the 3-month cold exposure intervention.

Trial sites (1)

More Renmin Hospital of Wuhan University trials in China

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