Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

NCT06619808 | Recruiting

• 1 other identifier: 2024DZKY-052-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metabolic Dysfunction-associated Steatotic Liver Disease; Hyperbaric Oxygen Therapy; Non-alcoholic Fatty Liver Diseases; Oxygen Therapy

Outcome Measures

Primary Outcomes (2)

• Change of liver stiffness

  We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography.

  Before the 1-month treatment, directly after the treatment, 6 months after the treatment

• Change of liver fat content

  We use controlled attenuation parameter (CAP) to evaluate liver fat content by Fibroscan noninvasive transient elastography.

  Before the 1-month treatment, directly after the treatment, 6 months after the treatment

Secondary Outcomes (5)

• Change of liver enzymes

  Before the 1-month treatment, directly after the treatment, 6 months after the treatment

• Change of fasting blood glugose

  Before the 1-month treatment, directly after the treatment, 6 months after the treatment

• 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

• change of total triglyceride

  Before the 1-month treatment, directly after the treatment, 6 months after the treatment

Other Outcomes (1)

• Safety of hyperbaric oxygen therapy

  After each session of HBOT and up to 6 months after the HBOT therapy.

Study Arms (2)

Hyperbaric Oxygen Therapy

EXPERIMENTAL

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).

Procedure: Hyperbaric oxygen therapy

Symptomatic Treatment

NO INTERVENTION

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

Interventions

Hyperbaric oxygen therapy 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).

Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metabolic dysfunction-associated steatotic liver disease patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Miaofang Yang, MD

  General Hospital of Eastern Theater Command, China

  STUDY DIRECTOR

Central Study Contacts

Lu Chen, MS

CONTACT

800-555-5555; 522023350160@smail.nju.edu.cn

Miaofang Yang, MD

CONTACT

doctor_yangmf@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: October 1, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)