Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

NCT ID: NCT06619808

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2026-08-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperbaric Oxygen Therapy

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).

Group Type: EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type: PROCEDURE

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).

Symptomatic Treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric 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).

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Lu Chen

MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miaofang Yang, MD

Role: STUDY_DIRECTOR

General Hospital of Eastern Theater Command, China

Locations

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Chen, MS

Role: CONTACT

522023350160@smail.nju.edu.cn

800-555-5555 ext. 86-18690113660

Miaofang Yang, MD

Role: CONTACT

doctor_yangmf@126.com

Facility Contacts

Lu Chen

Role: primary

522023350160@smail.nju.edu.cn

18690113660

Other Identifiers

2024DZKY-052-01

Identifier Type: -

Identifier Source: org_study_id