Metabolic Dysfunction-Associated Steatohepatitis (MASH)NCT07821749
A Prospective Study of Cold Exposure in Patients With MASH
A study testing Water-Perfused Cooling Suit in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- What is being tested?
- Water-Perfused Cooling Suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2026to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
Who cannot join
- 1. 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study of Cold Exposure Intervention in Patients With Metabolic Dysfunction-Associated Steatohepatitis
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.
Read the detailed description
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.
- Being tested
- Water-Perfused Cooling Suit
- Keywords
- MASH, MASLD, Cold Exposure, Water-Perfused Cooling Suit, Liver Fat
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-Perfused Cooling SuitDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Water-Perfused Cooling Suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months after cold exposure intervention
Secondary outcomes (6)
Change in Serum Alanine Aminotransferase (ALT) Levels
Change in serum alanine aminotransferase (ALT) levels from baseline to the end of the 3-month cold exposure intervention.
Measured: Baseline to 3 months after cold exposure intervention
Change in Serum Aspartate Aminotransferase (AST) Levels
Change in serum aspartate aminotransferase (AST) levels from baseline to the end of the 3-month cold exposure intervention.
Measured: Baseline to 3 months after cold exposure intervention
Change in Serum Triglyceride (TG) Levels
Change in serum triglyceride levels from baseline to the end of the 3-month cold exposure intervention.
Measured: Baseline to 3 months after cold exposure intervention
Change in Serum Total Cholesterol (TC) Levels
Change in serum total cholesterol levels from baseline to the end of the 3-month cold exposure intervention.
Measured: Baseline to 3 months after cold exposure intervention
Change in Body Weight and Body Mass Index (BMI)
Change in body weight and body mass index (BMI) from baseline to the end of the 3-month cold exposure intervention.
Measured: Baseline to 3 months after cold exposure intervention
Cold Exposure-Related Adverse Events
Incidence and severity of cold exposure-related adverse events, including discomfort, shivering, abnormal vital signs, and events requiring intervention during the study period.
Measured: Throughout the 3-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start8 Jul 2026
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821749
- Sponsor's protocol ID
- 2026240K
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications may be shared with qualified researchers upon reasonable request. Data sharing will be subject to approval by Zhongnan Hospital of Wuhan University and the institutional ethics committee, in accordance with applicable data management and privacy regulations.
Publications
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.
PubMed 40675156
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Cold Exposure Intervention in Patients With Metabolic Dysfunction-Associated Steatohepatitis
- ClinicalTrials.gov ID
- NCT07821749
- Acronym / sponsor ID
- 2026240K
- Keywords
- MASH, MASLD, Cold Exposure, Water-Perfused Cooling Suit, Liver Fat
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Exposure Intervention Using a Water-Perfused Cooling Suit | Experimental | Device: Water-Perfused Cooling SuitParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. 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.
Key exclusion criteria (1 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-Perfused Cooling SuitParticipants 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. | Device | Cold Exposure Intervention Using a Water-Perfused Cooling Suit |
Primary outcome
Change in Liver Fat Content Assessed by MRI-PDFF
Time frame: 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.
6 secondary outcomes
Change in Serum Alanine Aminotransferase (ALT) Levels
Time frame: Baseline to 3 months after cold exposure intervention
Change in Serum Aspartate Aminotransferase (AST) Levels
Time frame: Baseline to 3 months after cold exposure intervention
Change in Serum Triglyceride (TG) Levels
Time frame: Baseline to 3 months after cold exposure intervention
Change in Serum Total Cholesterol (TC) Levels
Time frame: Baseline to 3 months after cold exposure intervention
Change in Body Weight and Body Mass Index (BMI)
Time frame: Baseline to 3 months after cold exposure intervention
Cold Exposure-Related Adverse Events
Time frame: Throughout the 3-month intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 40675156Dumont 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications may be shared with qualified researchers upon reasonable request. Data sharing will be subject to approval by Zhongnan Hospital of Wuhan University and the institutional ethics committee, in accordance with applicable data management and privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-Perfused Cooling Suit in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Fat Content Assessed by MRI-PDFF (time frame: Baseline to 3 months after cold exposure intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.