Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD)

Jinling Hospital, China

Status: Enrolling

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Hepatic Steatosis; Non-alcoholic Fatty Liver Diseases

Treatments: Procedure: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06619808

2024DZKY-052-01

Details and patient eligibility

About

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.

Full description

Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) patients who meet our principles would be randomized into 2 groups: the HBOT group and CON group. The entire project is not blinded. In HBOT group, participants will receive HBOT for 20 times in 1 month (2.0ATA, 60min), which is the common setting in clinical use.The CON group, which means the control group, recerives regular drug, like liver-protective drugs and hypoglycemic drugs. The visiting times are week 0 (starting of the project), week 4 (ending of the therapy), week 28 (6 months after the therapy), when participants get checkups and tests. The primary outcome of our study are the change of liver fat content and stiffness in Fibroscan. The secondary outcomes invovle changes of liver function enzymes and metabolism.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Hyperbaric Oxygen Therapy

Experimental group

Description:

Participants receive 20 session of hyperbaric oxygen therapy (HBOT) in 1 month (inhalation of 100% oxygen in a pressure chamber under 2.0 ATA for 60 minutes).

Treatment:

Procedure: Hyperbaric oxygen therapy

Symptomatic Treatment

No Intervention group

Description:

Participants receive basic symptomatic treatments like antidiabetic drug, antihypertensive drug, and hepatic protector.