Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinling Hospital, China

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Metabolic dysfunction-associated steatotic liver disease patients

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric oxygen therapy

    Procedure/Surgery

    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).

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Hyperbaric Oxygen TherapyExperimental treatment 1 intervention
Group B: Symptomatic TreatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of liver stiffness

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

Time frame
Before the 1-month treatment, directly after the treatment, 6 months after the treatment
2

Change of liver fat content

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

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

Secondary outcomes

1

Change of liver enzymes

Alanine aminotransferase (ALT), aspertate aminotransferase(AST)

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

total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein(HDL-C)

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

Other outcomes

1

Safety of hyperbaric oxygen therapy

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

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

Sponsors and contacts

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