Hepatic Steatosis, Metabolic Dysfunction-associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Diseases
Conditions
Keywords
Metabolic Dysfunction-associated Steatotic Liver Disease, Hyperbaric Oxygen Therapy, Non-alcoholic Fatty Liver Diseases, Oxygen Therapy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHyperbaric oxygen therapy
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).
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of liver fat content | 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. |
| Change of liver stiffness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of fasting blood glugose | Before the 1-month treatment, directly after the treatment, 6 months after the treatment | — |
| Change of fasting insulin | Before the 1-month treatment, directly after the treatment, 6 months after the treatment | — |
| change of total triglyceride | Before the 1-month treatment, directly after the treatment, 6 months after the treatment | TG |
| Change of cholesterol | 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) |
| Change of liver enzymes | Before the 1-month treatment, directly after the treatment, 6 months after the treatment | Alanine aminotransferase (ALT), aspertate aminotransferase(AST) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of hyperbaric oxygen therapy | 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. |
Countries
China
Contacts
Primary ContactLu Chen, MS
Backup ContactMiaofang Yang, MD
Outcome results
None listed