Using hyperbaric oxygen therapy to treat liver diseases
Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
NA · Jinling Hospital, China · NCT06619808
This study is testing if hyperbaric oxygen therapy can help people with liver diseases by reducing liver fat and improving liver function compared to standard drug treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06619808 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hyperbaric oxygen therapy (HBOT) in treating Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD). Participants will be randomly assigned to either receive HBOT or standard drug treatment over a month, with follow-up assessments at the start, end, and six months post-therapy. The study aims to evaluate changes in liver fat content, fibrosis, and overall liver function. The primary outcomes focus on liver fat reduction and stiffness, while secondary outcomes include liver enzyme and metabolic changes.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Metabolic Dysfunction-associated Steatotic Liver Disease.
Not a fit: Patients with severe organ dysfunctions, certain liver diseases, or those unfit for hyperbaric treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve liver health and metabolic conditions in patients with MASLD.
How similar studies have performed: While hyperbaric oxygen therapy has been explored in various contexts, its application for MASLD is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metabolic dysfunction-associated steatotic liver disease patients Exclusion Criteria: * Participants are unfit for hyperbaric treatment. * Participants with prior oxygen therapy within the last 6 months. * Participants with history of viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency. * Participants with severe organ dysfunctions or malignant tumors. * Participants have weight loss plan or major operations within the last 6 months. * Participants are unable to provide informed consent or currently participating in or has within the last 3 months participated in any other clinical trial. * Participants are pregnant or lactating. * Participants with claustrophobia or that cannot decompress properly.
Where this trial is running
Nanjing, Jiangsu
- General Hospital of Eastern Theater Command — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Lu Chen, MS
- Email: 522023350160@smail.nju.edu.cn
- Phone: 800-555-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis, Non-alcoholic Fatty Liver Diseases, Hyperbaric Oxygen Therapy, Oxygen Therapy