A Prospective Study of Cold Exposure in Patients With MASH

NCT07821749 | Active Not Recruiting

• 1 other identifier: 2026240K
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Keywords

MASH; MASLD; Cold Exposure; Water-Perfused Cooling Suit; Liver Fat

Outcome Measures

Primary Outcomes (1)

• Change in Liver Fat Content Assessed by MRI-PDFF

  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.

  Baseline to 3 months after cold exposure intervention

Secondary Outcomes (6)

• 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

Study Arms (1)

Cold Exposure Intervention Using a Water-Perfused Cooling Suit

EXPERIMENTAL

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.

Device: Water-Perfused Cooling Suit

Interventions

Water-Perfused Cooling Suit DEVICE

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.

Cold Exposure Intervention Using a Water-Perfused Cooling Suit

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults aged 18 to 70 years. 2. Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). 3. Able to understand and provide written informed consent. 4. Willing to comply with the study intervention and follow-up assessments.

You may not qualify if:

• \. Significant alcohol consumption or other causes of chronic liver disease. 2. Severe cardiovascular, respiratory, renal, or other systemic diseases. 3. Conditions contraindicating cold exposure. 4. Pregnancy or breastfeeding. 5. Use of medications or participation in other clinical studies that may significantly affect metabolic outcomes.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (1)

• Dumont L, Richard G, Espagnet R, Frisch F, Fortin M, Samson A, Bouchard J, Fontaine R, Croteau E, Phoenix S, Dubreuil S, Guerin B, Turcotte EE, Carpentier AC, Blondin DP. Shivering, but not adipose tissue thermogenesis, increases as a function of mean skin temperature in cold-exposed men and women. Cell Metab. 2025 Sep 2;37(9):1789-1805.e4. doi: 10.1016/j.cmet.2025.06.010. Epub 2025 Jul 16.

  PMID: 40675156 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-arm study in which all participants receive repeated cold exposure using a water-perfused cooling suit. Clinical, metabolic, and hepatic outcomes are compared within participants between baseline and the end of the 3-month intervention.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 16, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the main study results and available for 5 years.
• Access Criteria: De-identified individual participant data will be available to qualified researchers upon reasonable request for scientifically appropriate purposes. Requests will be reviewed by the study investigators and relevant institutional authorities. Data sharing will require approval from Zhongnan Hospital of Wuhan University and, when applicable, the institutional ethics committee, in accordance with institutional data management and privacy policies.

Locations

CN (1)