NCT07821749Active, not recruiting
A Prospective Study of Cold Exposure in Patients With MASH
A Prospective Clinical Study of Cold Exposure Intervention in Patients With Metabolic Dysfunction-Associated Steatohepatitis
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 9 Sept 2026
- Start date
- 8 Jul 2026
- Primary completion date
- 8 Oct 2026
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07821749
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 8 Jul 2026 to the primary completion date, 8 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.