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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | 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). |
|
| Symptomatic Treatment | No Intervention | Participants receive basic symptomatic treatments like antidiabetic drug, antihypertensive drug, and hepatic protector. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen therapy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of liver stiffness | We use E value to describe liver stiffness by Fibroscan noninvasive transient elastography. | 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. | Before the 1-month treatment, directly after the treatment, 6 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of liver enzymes | Alanine aminotransferase (ALT), aspertate aminotransferase(AST) | Before the 1-month treatment, directly after the treatment, 6 months after the treatment |
| Change of fasting blood glugose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of hyperbaric oxygen therapy | We conduct questionnaires of adverse reaction after every therapy time and follow-up visit. | After each session of HBOT and up to 6 months after the HBOT therapy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Chen, MS | Contact | 800-555-5555 | 86-18690113660 | 522023350160@smail.nju.edu.cn |
| Miaofang Yang, MD | Contact | doctor_yangmf@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Miaofang Yang, MD | General Hospital of Eastern Theater Command, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Eastern Theater Command | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| 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 cholesterol | total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein(HDL-C) | Before the 1-month treatment, directly after the treatment, 6 months after the treatment |
| change of total triglyceride | TG | Before the 1-month treatment, directly after the treatment, 6 months after the treatment |