RecruitingNot ApplicableNCT06619808

Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial

Sponsor

Jinling Hospital, China

Enrollment

150 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease Hepatic Steatosis Non-alcoholic Fatty Liver Diseases

Summary

The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) works to treat Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD). The main questions it aims to answer are: Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients? Does HBOT improves the liver function and metabolic condition in adult MASLD patients? Participants will: Receive HBOT for 20 times in 1 month or recerive regular drug; Visit the clinic for checkups and tests at the starting, ending of the therapy and 6 month after the therapy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

Metabolic dysfunction-associated steatotic liver disease patients

Exclusion Criteria8

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.

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Interventions

PROCEDUREHyperbaric oxygen therapy

Participants receive 20 session of hyperbaric oxygen therapy (HBOT) in one month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes).