A Prospective Clinical Study of Cold Exposure Intervention in Patients With Metabolic Dysfunction-Associated Steatohepatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Liver Fat Content Assessed by MRI-PDFF
研究概览
简要总结
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.
详细描述
This is a single-center, single-arm, prospective, exploratory clinical study designed to investigate the feasibility, safety, and short-term effects of repeated cold exposure in patients with metabolic dysfunction-associated steatohepatitis (MASH). Eleven participants will be enrolled and will serve as their own controls, with clinical and metabolic parameters compared between baseline and the end of the intervention.
Participants will undergo repeated cold exposure using a water-perfused cooling suit for 3 months. Cold exposure will generally be performed once daily for approximately 120 minutes. Each session will include a 10- to 15-minute adaptation period, during which the circulating-water temperature will be gradually reduced toward a target temperature of approximately 22°C according to individual tolerance. The actual circulating-water temperature, exposure duration, tolerability, and any adverse reactions will be recorded for each session. Blood pressure, heart rate, body temperature, shivering, and subjective discomfort will be monitored during the intervention.
Baseline assessments will include clinical evaluation, blood biochemical testing, MRI-PDFF for liver fat quantification, liver ultrasound, and noninvasive liver fibrosis assessment. After completion of the 3-month intervention, these assessments will be repeated. Changes in MRI-PDFF, ALT, AST, TG, TC, body weight, and body mass index will be evaluated as major clinical outcomes. Additional assessments will include liver ultrasound or liver stiffness-related measures, noninvasive fibrosis scores such as FIB-4 and NFS, and FibroScan or equivalent liver stiffness assessment when available.
Safety outcomes will include adverse events, serious adverse events, cold-related discomfort, and abnormalities in vital signs. Feasibility outcomes will include study completion, adherence, and actual duration of cold exposure. Dietary intake, physical activity, body weight, and concomitant medications will also be recorded during the study to assist with interpretation of the observed changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults aged 18 to 70 years.
- •Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH).
- •Able to understand and provide written informed consent.
- •Willing to comply with the study intervention and follow-up assessments.
排除标准
- •1. Significant alcohol consumption or other causes of chronic liver disease.
- •Severe cardiovascular, respiratory, renal, or other systemic diseases.
- •Conditions contraindicating cold exposure.
- •Pregnancy or breastfeeding.
- •Use of medications or participation in other clinical studies that may significantly affect metabolic outcomes.
研究组 & 干预措施
Cold Exposure Intervention Using a Water-Perfused Cooling Suit
Participants will undergo repeated cold exposure using a water-perfused cooling suit once daily for approximately 120 minutes over a 3-month intervention period. The target circulating-water temperature is approximately 22°C and may be adjusted according to individual tolerance. Each session includes a 10- to 15-minute adaptation period, and vital signs, shivering, subjective discomfort, exposure duration, and tolerability are monitored and recorded.
干预措施: Water-Perfused Cooling Suit (Device)
结局指标
主要结局
Change in Liver Fat Content Assessed by MRI-PDFF
时间窗: 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.
次要结局
- Change in Serum Alanine Aminotransferase (ALT) Levels(Baseline to 3 months after cold exposure intervention)
- Change in Serum Aspartate Aminotransferase (AST) Levels(Baseline to 3 months after cold exposure intervention)
- Change in Serum Triglyceride (TG) Levels(Baseline to 3 months after cold exposure intervention)
- Change in Serum Total Cholesterol (TC) Levels(Baseline to 3 months after cold exposure intervention)
- Change in Body Weight and Body Mass Index (BMI)(Baseline to 3 months after cold exposure intervention)
- Cold Exposure-Related Adverse Events(Throughout the 3-month intervention period)
研究者
ChenMingkai
Principal Investigator
Renmin Hospital of Wuhan University