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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Hyperbaric oxygen therapy
Procedure/SurgeryParticipants 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
Trial outcomes
Primary outcomes
Change of liver stiffness
We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography.
Change of liver fat content
We use controlled attenuation parameter (CAP) to evaluate liver fat content by Fibroscan noninvasive transient elastography.
Secondary outcomes
Change of liver enzymes
Alanine aminotransferase (ALT), aspertate aminotransferase(AST)
Change of fasting blood glugose
Change of fasting insulin
Change of cholesterol
total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein(HDL-C)
Other outcomes
Safety of hyperbaric oxygen therapy
We conduct questionnaires of adverse reaction after every therapy time and follow-up visit.
Sponsors and contacts
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