Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric oxygen therapy.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, Hepatic Steatosis, Non-alcoholic Fatty Liver Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Hyperbaric Oxygen Therapy in Adult Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD) Patients : a Randomized Controlled Trial
Overview
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
- Procedure Hyperbaric 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).
Primary outcome measures
- Change of liver stiffness [Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- Change of liver fat content [Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
Secondary outcome measures (5)
- Change of liver enzymes [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 [Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
- change of total triglyceride [Time frame: Before the 1-month treatment, directly after the treatment, 6 months after the treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- General Hospital of Eastern Theater Command — Nanjing
Identifiers
NCT: NCT06619808 · 2024DZKY-052-01