An interventional study of Hyperbaric oxygen therapy in Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis and Non-alcoholic Fatty Liver Diseases, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants receive basic symptomatic treatments like antidiabetic drug, antihypertensive drug, and hepatic protector.
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).
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
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
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.
Plan to share: No — Not suitable
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Jinling Hospital, China