Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

Not Applicable

Recruiting

• Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Hepatic Steatosis; Non-alcoholic Fatty Liver Diseases
• Interventions: Procedure: Hyperbaric oxygen therapy

• Registration Number: NCT06619808
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2024-07-29
• Study First Submitted: 2024-08-11
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-28
• Last Update Submitted: 2024-09-28
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy	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).

Primary Outcome Measures

Name	Time	Method
Change of liver stiffness	Before the 1-month treatment, directly after the treatment, 6 months after the treatment	We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography.
Change of liver fat content	Before the 1-month treatment, directly after the treatment, 6 months after the treatment	We use controlled attenuation parameter (CAP) to evaluate liver fat content by Fibroscan noninvasive transient elastography.

Secondary Outcome Measures

Name	Time	Method
Change of liver enzymes	Before the 1-month treatment, directly after the treatment, 6 months after the treatment	Alanine aminotransferase (ALT), aspertate aminotransferase(AST)
Change of fasting blood glugose	Before the 1-month treatment, directly after the treatment, 6 months after the treatment
change of total triglyceride	Before the 1-month treatment, directly after the treatment, 6 months after the treatment	TG
Change of fasting insulin	Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of cholesterol	Before the 1-month treatment, directly after the treatment, 6 months after the treatment	total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein(HDL-C)

Trial Locations

Locations (1)

General Hospital of Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China