Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

Phase

N/A

Condition

Liver Disease

Hepatic Fibrosis

Primary Biliary Cholangitis

Treatment

Hyperbaric oxygen therapy

Clinical Study ID

NCT06619808

2024DZKY-052-01

Ages 18-75
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Metabolic dysfunction-associated steatotic liver disease patients

Exclusion

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, biliaryobstruction, 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 orhas within the last 3 months participated in any other clinical trial.
Participants are pregnant or lactating.
Participants with claustrophobia or that cannot decompress properly.

Study Design

Hyperbaric oxygen therapy

July 29, 2024

August 31, 2026

Study 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.

Connect with a study center

General Hospital of Eastern Theater Command
Nanjing, Jiangsu 210000
China
Active - Recruiting

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