Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06619808

Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change of liver stiffness

    Time frame: 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.

  2. Change of liver fat content

    Time frame: 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 outcomes

  1. Change of liver enzymes

    Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment

    Alanine aminotransferase (ALT), aspertate aminotransferase(AST)

  2. Change of fasting blood glugose

    Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment

  3. Change of fasting insulin

    Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment

  4. Change of cholesterol

    Time frame: 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)

  5. change of total triglyceride

    Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment

    TG

Other outcomes

  1. Safety of hyperbaric oxygen therapy

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

    We conduct questionnaires of adverse reaction after every therapy time and follow-up visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Chen, MS

CONTACT

[email protected]

800-555-5555 ext. 86-18690113660

Miaofang Yang, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial

Acronym: MASLD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.