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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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).
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
RECRUITINGChange 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
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
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
Change of fasting blood glugose
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
Change of fasting insulin
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
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
change of total triglyceride
TG
Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment
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